The Food and Drug Administration ( FDA or USFDA ) is a federal agent of the United States Department of Health and Human Services, one of United States the federal executive department. The FDA is responsible for protecting and promoting public health through the control and control of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation. emitting devices (ERED), cosmetics, animal foods & amp; feed and animal products. By 2017, 3/4 of the FDA's budget (about $ 700 million) is funded by pharmaceutical companies because of the Prescription Drug Usage Fees Act.
The FDA is empowered by the United States Congress to enforce the Federal Food, Drug and Cosmetic Act, which serves as the primary focus for the Agency; The FDA has also enacted other laws, notably Section 361 of the Health Service Act and related regulations, many of which are not directly related to food or medicine. This includes regulating lasers, cell phones, condoms and disease control on products ranging from certain domestic pets to sperm donations for aid reproduction.
The FDA is headed by the Food and Drug Administration, who is appointed by the President with advice and approval from the Senate. The Commissioner reports to the Secretary of Health and Human Services. Scott Gottlieb, M.D. is the current commissioner, which took over in May 2017.
The FDA has its headquarters in White Oak, Maryland. It also has 223 field offices and 13 laboratories located in 50 states, the US Virgin Islands and Puerto Rico. In 2008, the FDA began to send employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
Video Food and Drug Administration
Organizational chart
Maps Food and Drug Administration
Location
In recent years, the agency has begun a large-scale effort to consolidate its 25 operations in the Washington metropolitan area, moving from its main headquarters in Rockville and some sprawling offices to the former Naval Ordnance Laboratory site in the White Oak area. from Silver Spring, Maryland. The site was renamed from the White Oak Naval Surface Warfare Center to the Federal Research Center at White Oak. The first building, the Science Laboratory, was dedicated and opened with 104 employees on campus in December 2003. Only one original building of the naval facility was kept. All other buildings are new construction. The project is scheduled to be completed by 2017, assuming future Congress funding
Regional facilities
While most Centers are located in the Washington, DC area as part of the Headquarters division, two offices - the Office of Regulatory Affairs (ORA) and the Criminal Investigation Office - primarily field offices with employment dispersal. cross country.
The Regulatory Affairs Office is considered the "eye and ear" of the agency, doing most of the FDA work in the field. Consumer Safety Officers, more commonly called Investigators, are individuals who check production facilities and warehousing, investigate complaints, diseases, or outbreaks, and review documentation in case of medical devices, drugs, biological products, and other items that may be difficult to perform a physical examination or take a physical sample of the product.
The Office of Regulatory Affairs is divided into five areas, divided into 20 districts. The district is roughly based on the geographical divisions of the federal court system. Each district consists of the main district office and a number of Population Post, which is the FDA's long-distance office serving a certain geographical area. ORA also includes the Agency's laboratory regulatory network, which analyzes each physical sample taken. Although samples are typically associated with food, several laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices.
The Office of Criminal Investigation was established in 1991 to investigate criminal cases. Unlike ORA Investigators, OCI Special Agents have weapons, and do not focus on the technical aspects of the regulated industry. OCI agents pursue and develop cases in which individuals and companies have committed criminal acts, such as fraudulent claims, or deliberately and deliberately delivering rejuvenated goods in interstate commerce. In many cases, OCI pursues cases involving Title 18 violations (for example, conspiracy, false statements, wire fraud, letter fraud), in addition to prohibited actions as defined in Chapter III of the FD & C. OCI Special Agent often comes from other criminal investigation background, and cooperates with Federal Bureau of Investigation, Assistant Attorney General, and even Interpol. OCI accepts cases from multiple sources - including ORA, local agents, and FBI - and works with ORA Investigators to help develop the technical and science aspects of a case. OCI is a smaller branch, consisting of about 200 national agents.
The FDA often works with other federal agencies, including the Department of Agriculture, the Drug Eradication Administration, Customs and Border Protection, and the Consumer Product Safety Commission. Often local and state government agencies also work with the FDA to provide regulatory inspection and enforcement action.
Coverage and funding
The FDA regulates consumer goods worth more than 2.4 trillion US dollars, about 25% of consumer spending in the United States. These include $ 466 billion in food sales, $ 275 billion in drugs, $ 60 billion in cosmetics and $ 18 billion in vitamin supplements. Much of this expenditure is for goods imported into the United States; The FDA is responsible for monitoring imports.
FDA's federal budget request for the fiscal year (FY) 2012 reaches $ 4.36 billion, while the proposed 2014 budget is $ 4.7 billion. About $ 2 billion of this budget is generated by user fees. Pharmaceutical companies pay most of these fees, which are used to speed up drug reviews. FDA's federal budget request for the fiscal year 2008 (October 2007 to September 2008) totaled $ 2.1 billion, an increase of $ 105.8 million from what was received for fiscal 2007.
In February 2008, the FDA announced that the Federal Government's 2009 budget request for the agency was just under $ 2.4 billion: $ 1.77 billion in budget authority (federal funding) and $ 628 million in user fees. The requested budget authority was a $ 50.7 million increase over FY 2008 funding - around a three percent increase. In June 2008, Congress provided the agency with emergency aid of $ 150 million for FY 2008 and another $ 150 million.
Most federal laws on the FDA are part of the Food, Drug and Cosmetic Act, (first authorized in 1938 and amended extensively since) and codified in Title 21, Chapter 9 of the United States Code. Other important laws enforced by the FDA include the Public Health Service Act, part of the Controlled Substance Act, Federal Anti-Disorder Act, and many others. In many cases, this responsibility is shared with other federal agencies.
Regulatory program
By 2015, the agency organizes more than $ 1 trillion in consumer products, including:
- $ 466 billion in food
- $ 275 billion in medicine
- $ 60 billion in cosmetics
- $ 18 billion in vitamin supplements
The program for safety regulation varies greatly according to product type, potential risks, and regulatory powers granted to the agency. For example, the FDA regulates almost every aspect of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety - but FDA cosmetic regulation focuses primarily on labeling and security. The FDA regulates most products with a series of published standards enforced by a number of simple facility checks. Inspection observations are documented in Form 483.
Canada-United States Arrangement Coordination Council
On February 4, 2011, Canadian Prime Minister Stephen Harper and United States President Barack Obama issued a "Declaration on the Common Vision for Perimeter Security and Economic Competitiveness" and announced the creation of the Council of Canada-United States Regulatory Cooperation (RCC) "to improve regulatory and coordination transparency between the two countries ".
Canadian Health and the United States Food and Drug Administration (FDA) under the mandate of the RCC, initiated the "first of its kind" by selecting "as the first area of ​​general cold indication alignment for certain over-the-counter antihistamine (GC 2013-01 -10). "
Food and food supplements
The regulation of diet and dietary supplements by the US Food and Drug Administration is governed by various laws passed by the United States Congress and interpreted by the FDA. Under the Federal Food, Drug and Cosmetics Act (the "Act") and its accompanying laws, the FDA has the authority to monitor the quality of substances sold as food in the United States, and to monitor claims made in the label about both. composition and health benefits of food.
The FDA divides the substances it regulates as food into various categories - including food, food additives, additives (artificial substances that are not deliberately inserted into the food but end up in it), and dietary supplements. Specific FDA practice standards differ from one category to the next. In addition, the law has provided the FDA various ways to address standard violations for certain substance categories.
"FDA - Approved "vs." FDA-Received in Food Processing "
The FDA does not approve the use of coatings used in the food processing industry. There is no review process to approve non-stick coating compositions, nor does the FDA inspect or test these materials. Through their process arrangement, however, the FDA does have a set of rules covering the formulation, manufacturing, and use of nonstick coatings. Therefore, materials such as Polytetrafluoroethylene (Teflon) are not, and can not be, considered as FDA Approved; rather, they are "FDA Compliant" or "FDA Acceptable".
Drugs
The Center for Evaluation of Drugs and Research uses different requirements for three major drug products: new drugs, generic drugs, and over-the-counter medicines. A drug is considered "new" if made by a different manufacturer, using different excipients or inactive materials, used for different purposes, or undergoing substantial change. The most stringent requirements apply to the new molecular entity : drugs that are not based on existing drugs.
New drug
New drugs receive widespread oversight before FDA approval in a process called a new drug application (NDA). Critics, however, argue that FDA standards are not strict enough, allowing unsafe or ineffective drugs to be approved. New drugs are only available by prescription by default. Over-the-counter (OTC) status changes are a separate process, and drugs must be approved through the first NDA. Approved drugs are said to be "safe and effective when used as directed".
Some very rare limited exceptions for multi-step processes involving animal testing and controlled clinical trials can be provided from compassionate use protocols, such as those occurring during the Ebola 2015 epidemic with use, with prescription and authorization, from ZMapp and other experiments. care and for new drugs that can be used to treat debilitating and/or extremely rare conditions where no drug or drug is present satisfactorily, or where there has been no progression for long periods of time. The study grew longer, gradually adding more individuals as they progressed from stage I to stage III, usually for several years, and usually involved drug companies, governments and laboratories, and often medical schools and hospitals and clinics. However, exceptions to the above mentioned processes are subject to rigorous review and examination and conditions, and are only provided if a large amount of research and at least some early human testing have shown that they are believed to be somewhat secure and may be effective.
Ads and promotions
The FDA Office of Prescription Drug Promotion reviews and manages the advertising and promotion of prescription drugs through surveillance activities and the issuance of law enforcement letters to pharmaceutical manufacturers. Advertising and promotions for over-the-counter medicines are sold by the Federal Trade Commission.
The drug advertising regulations contain two broad terms: (1) the company may advertise or promote the drug only for special indications or medical uses approved by the FDA. Also, advertising must contain a "fair balance" between the benefits and risks (side effects) of a drug.
The term off-label refers to the use of drugs for indications other than those approved by the FDA.
Post-customer security supervision
Upon approval of the NDA, the sponsor should review and report to the FDA any drug experience experienced by the patient. They should report a fatal and fatal accidental drug event within 15 days, and other events every three months. The FDA also received reports of adverse drug events directly through the MedWatch program. These reports are called "spontaneous reports" because reporting by consumers and health professionals is voluntary.
While this remains a key tool of post-marketing security surveillance, FDA requirements for post-marketing risk management are increasing. As a condition of approval, sponsors may be required to perform additional clinical trials, called Phase IV trials. In some cases, the FDA requires a risk management plan ("Risk Evaluation and Mitigation Strategy" or "REMS") for some drugs that require action to be taken to ensure that the drug is used safely. For example, thalidomide can cause birth defects but has a greater than risk use if the men and women who use the drug do not conceive; the REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many opioid drugs have REMS programs to avoid addiction and drug diversion. There is also a REMS program called iPLEDGE for medicine, isotretinoin.
Generic drugs
Generic drugs are the chemical equivalent of branded drugs whose patents have expired. In general, they are cheaper than their name brand counterparts, manufactured and marketed by other companies and, in the 1990s, accounted for about a third of all the recipes written in the United States. For generic drug approval, the US Food and Drug Administration (FDA) requires scientific evidence that generic drugs may be exchanged for drugs or equivalent to previously approved drugs. This is called "YOU" (Abbreviated New Drug Application). In 2012, 80% of all FDA-approved drugs are available in generic form.
Generic drug scandal
In 1989, a major scandal erupted involving procedures used by the FDA to approve generic drugs for sale to the public. The allegations of corruption in generic drug approvals first appeared in 1988, in the course of an extensive congressional inquiry into the FDA. The supervisory subcommittee of the United States Trade and Energy Committee of the United States was generated from complaints filed against the FDA by Mylan Laboratories Inc. from Pittsburgh. When his application to produce generic drugs became the target of a recurring delay by the FDA, Mylan, convinced that it was being discriminated, immediately began a private investigation of the agent in 1987. Mylan eventually filed a lawsuit against two former FDA employees and four drug-manufacturing companies alleging that corruption within federal agencies leads to extortion and antitrust law violations. "The order in which new generic drugs are approved is set by FDA employees even before drug manufacturers submit applications" and, according to Mylan, this illegal procedure is followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of taking bribes from generic drug makers, and two companies (Par Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to bribe.
In addition, it was found that some manufacturers have falsified data submitted in search of FDA authorizations to market certain generic drugs. Vitarine Pharmaceuticals of New York, which seeks approval from the generic version of the Dyazide drug, a drug for high blood pressure, submits Dyazide, rather than its generic version, to the FDA test. In April 1989, the FDA investigated 11 producers for irregularities; and then carry that number up to 13. Dozens of drugs were eventually suspended or withdrawn by the manufacturer. In the early 1990s, the US Securities and Exchange Commission filed a securities fraud suit against Bolar Pharmaceutical Company, a large generic manufacturer based in Long Island, New York.
Over-the-counter drugs
Over-the-counter (OTC) drugs such as aspirin are drugs and combinations that do not require a doctor's prescription. The FDA has a list of about 800 approved ingredients that are combined in various ways to create over 100,000 free drug products. Many of the OTC drug ingredients have previously approved prescription drugs now considered safe enough to be used without the supervision of medical practitioners such as ibuprofen.
Ebola Treatment
In 2014, the FDA added Ebola treatment developed by Canadian pharmaceutical company Tekmira to the Fast Track program, but halted phase 1 trials in July pending further acceptance of how the drug worked. This is seen as increasingly important in the face of a major outbreak of disease in West Africa beginning in late March 2014 and continuing in August 2014.
Vaccines, blood and tissue products, and biotechnology
The Center for Evaluation and Biological Research is a branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenic, cell and tissue-based products, and gene therapy products. New biologics are required to go through a pre-marketing approval process called the Biological License Application (BLA), similar to that for drugs.
The original authority for government regulation of biological products was established by the 1902 Biological Control Act, with additional authority established by the 1944 Public Health Service Act. Together with these Acts, the Federal Food, Drug and Cosmetic Act applies to all biological products as well. Initially, the entity responsible for the regulation of biological products under the National Institutes of Health; this authority was transferred to the FDA in 1972.
Radio transmitter and transmitter
The Center for Devices and Radiological Health (CDRH) is a branch of the FDA responsible for premarket approval of all medical devices, as well as overseeing the manufacturing, performance and security of these devices. Medical device definitions are given in the FD & amp; C, and that includes products from simple toothbrushes to complex devices such as neurostimulator implants. CDRH also oversees the safety performance of non-medical devices that emit certain types of electromagnetic radiation. Examples of CDRH-set devices include cell phones, airport luggage inspection equipment, television receivers, microwave ovens, tanning chambers, and laser products.
The regulatory strength of the CDRH includes the authority to request certain technical reports from regulated manufacturers or regulated importers, to require that radiation-emitting products meet mandatory safety performance standards, to declare defective products, and to order withdrawal of defective or non-compliant products. CDRH also conducts direct product testing in limited quantities.
"FDA-Cleared" vs. "FDA Approved"
Permission requests are for medical devices proving that they are "substantially equivalent" with predicate devices already in the market. Approved requests are for new or very different items and need to show "safety and efficacy", for example it can be checked for safety if there is a new toxic hazard. Both aspects need to be proven or provided by the sender to ensure proper procedures are followed.
Cosmetics
Cosmetics is regulated by the Center for Food Safety and Applied Nutrition, the same FDA branch that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structural or functional claims" that make it into drugs (see Cosmeceutical). However, all color additives must be FDA approved specifically before manufacturers can include them in cosmetic products sold in the US. The FDA regulates cosmetic labeling, and cosmetics that have not yet been tested for security should provide warnings for such effects.
Although the cosmetic industry is largely responsible for ensuring the safety of its products, the FDA also has the power to intervene when necessary to protect the public but generally does not require pre-market approval or testing. Companies are required to place a warning note on their products if they have not been tested. Experts in cosmetic material reviews also play a role in monitoring security through influence on the use of materials, but also do not have legal authority. Overall the organization has reviewed about 1,200 materials and has suggested that several hundred should be restricted, but there is no standard or systemic method for reviewing chemicals for safety and a clear definition of what is meant by 'safety' so that all chemicals are tested on the basis of which same.
Veterinary products
The Center for Veterinary Medicine (CVM) is a branch of the FDA that regulates food additives and medicines administered to animals. CVM does not regulate vaccines for animals; this is handled by the United States Department of Agriculture.
The main focus of CVM is on medicines used in animal foods and ensuring that they do not affect the human food supply. The FDA requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through the inspection of feed manufacturers.
Tobacco products
Since the Family Smoking Prevention and Tobacco Control Act became law in 2009, the FDA also has the authority to regulate tobacco products.
In 2009, Congress issued legislation requiring color warnings on cigarette packs and print ads, in addition to text warnings from US Surgeon General.
Nine new graphical warning labels announced by the FDA in June 2011 and are scheduled to be required to appear on the packaging in September 2012. The date of implementation is uncertain, due to the ongoing process in the case of R.J. Reynolds Tobacco Co. v. US Food and Drug Administration. R.J. Reynolds, Lorillard, Commonwealth Brands Inc., Liggett Group LLC and Santa Fe Natural Tobacco Company Inc. has filed a lawsuit in federal court in Washington, DC which claims that graphic labels are an unconstitutional way that forces tobacco companies to engage in anti-smoking advocacy on behalf of the government.
A First Amendment lawyer, Floyd Abrams, representing tobacco companies in this case, demanded that graphic warning labels on legitimate products could not withstand constitutional scrutiny. The National Advertising Association and the American Advertising Federation have also filed briefly in the lawsuit, arguing that the label violates commercial freedom of speech and could lead to further government intrusion if left unchallenged. In November 2011, Federal Judge Richard Leon of the US District Court for the District of Columbia suspended a new label, possibly delaying the requirement that tobacco companies display labels. The US Supreme Court can finally decide on this issue.
In July 2017, the FDA announced a plan that would reduce the current level of nicotine allowed in tobacco cigarettes.
Regulation of living organism
With the receipt of a 510 (k) k033391 premarket notification in January 2004, the FDA granted permission to Dr. Ronald Sherman to produce and market medical maggots for use in humans or other animals as a prescribed medical device. The medical maggots are the first living organism permitted by the Food and Drug Administration for production and marketing as prescribed medical devices.
In June 2004, the FDA cleared the Hirudo medicinalis (medicinal leech) as a second living organism used as a medical device.
The FDA also needs milk to be pasteurized to remove bacteria.
Science and research programs
In addition to its regulatory functions, the FDA conducts research and development activities to develop technologies and standards that support its regulatory role, with the aim of solving scientific and technical challenges before it becomes an obstacle. FDA's research efforts include areas of biology, medical equipment, medicine, women's health, toxicology, food safety and applied nutrition, and veterinary medicines.
Data management
The FDA has been collecting huge amounts of data for decades. In March 2013, OpenFDA was created to allow easy data access for the public.
History
Until the 20th century, there were several federal laws governing the content and sale of domestically produced foods and medicines, with one exception being the short-lived 1813 Vaccine Act. The history of the FDA can be traced back to the end of the 19th Century and the Chemistry Division of the US Department of Agriculture, which later became the Chemistry Bureau. Under Harvey Washington Wiley, who was appointed chief chemist in 1883, the Division began research on counterfeiting and misstatements on food and medicine. in the American market. Wiley's advocacy comes at a time when the public has become aroused by dangers in the market by muckraking journalists such as Upton Sinclair, and became part of a general trend for increased federal regulation in matters relating to public safety during the Progressive Era. The Biological Control Act of 1902 came into effect after diphtheria antitoxin - derived from tetanus-contaminated serum - used to produce a vaccine that caused the deaths of thirteen children at St. Louis, Missouri. The serum was originally taken from a horse named Jim, who contracted tetanus.
In June 1906, President Theodore Roosevelt signed a law on the Food and Pure Drug Act, also known as the "Wiley Act" after his main advocate. The law is prohibited, under the threat of seizure of goods, transport interstate food that has been "forged". This law imposes a similar punishment on the interstate marketing of "contaminated" drugs, in which "the strength, quality or purity standard" of the active ingredient is not clearly specified on the label or registered in the United States Pharmacopoeia. or the National Formulary.
The responsibility for examining such food and drugs for such "forgery" or "misconduct" is given to Wiley's USDA Bureau of Chemistry. Wiley used this new regulatory powers to pursue an aggressive campaign against food producers with additional chemicals, but the Bureau of Chemistry authorities were soon questioned by judicial decisions, narrowly defining bureau powers and setting high standards for evidence of fraudulent intent. In 1927, the regulatory power of the Chemistry Bureau was reorganized under the new USDA agency, the Food, Drugs and Insecticides Organization. The name was shortened to the Food and Drug Administration (FDA) three years later.
In the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began advancing campaigns for stronger regulatory authorities by publishing a list of hazardous products that had been ruled allowed under the 1906 law, including radioactive drinks, Lash mascara Lash, causing blindness, and "drugs" that are useless for diabetes and tuberculosis. The proposed legislation could not pass the United States Congress for five years, but was quickly passed into law after public condemnation of the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using drugs poisoned with toxins. , an untested solvent.
President Franklin Delano Roosevelt signed the new Food, Drug and Cosmetics Act (FD & C Act) into law on June 24, 1938. This new law significantly increases the federal regulatory authority over drugs by requiring a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labels without requiring the FDA to prove fraudulent intent. Immediately after the passage of the 1938 Act, the FDA began appointing certain drugs as safe for use only under the supervision of a medical professional, and the "specialty prescription" category was safely codified into law by 1951 Durham-Humphrey Amendment. This development underscores the vast force for the FDA to enforce ineffective post-marketing ineffective drugs.
In 1959, the tragedy of thalidomide, where thousands of European babies were born disabled after their mothers took a drug that was marketed for the treatment of nausea - during their pregnancy, Considering the US was largely spared the tragedy. Frances Oldham Kelsey of the FDA refused to authorize drugs for the market, 1962 Kefauver-Harris Changes to FD & amp; C is passed, representing a "revolution" within the FDA regulatory authorities. The most important change is the requirement that all new drug applications show "substantial evidence" of drug efficacy for marketable indications, in addition to the existing requirements for pre-marketing safety demonstrations. This marked the start of the FDA approval process in its modern form.
This reform has the effect of increasing the time, and the difficulty, necessary to bring the drug to the market. One of the most important laws in establishing the modern American pharmaceutical market is the 1984 Drugs Competition and the Patent Reconstruction Act, better known as the "Hatch-Waxman Act" after its main sponsors. The law extends the exclusivity rights of new drug patents, and binds those extensions, in part, to the length of the FDA approval process for each drug. For generic manufacturers, the Law creates a new approval mechanism, the Application of New Drugs Abbreviated (YOU), where generic drug manufacturers only need to show that their generic formulations have the same active ingredients, delivery routes, dosage form, strength, and pharmacokinetic properties "bioequivalent") as an appropriate branded drug. This action has been credited in essence creating a modern generic drug industry.
Concerns about the length of the drug approval process were brought forward at the start of the AIDS epidemic. In the mid- and late-1980s, ACT-UP and other HIV activist organizations accused the FDA of not having to delay drug approval against HIV and opportunistic infections. In part in response to this criticism, the FDA issued new rules to speed up drug approval for life-threatening illnesses, and expanded pre-approval access to drugs for patients with limited treatment options. All approved early drugs for the treatment of HIV/AIDS are approved through this accelerated approval mechanism. Frank Young, FDA's commissioner is behind the Phase II Action Plan, which was established in August 1987 for faster AIDS drug approval.
In two instances, the state government has sought to legalize drugs that have not been approved by the FDA. Based on the theory that federal laws passed in accordance with the authority of the Constitution override contradictory state laws, federal authorities still claim authority to capture, capture, and prosecute the ownership and sale of these substances, even in countries where they are legal under state law. The first wave was legalized by 27 states of laetrile in the late 1970s. The drug is used as a treatment for cancer, but scientific studies both before and after this legislative trend find it to be ineffective. The second wave was associated with medical marijuana in the 1990s and 2000s. Although Virginia passed a law with limited effect in 1979, a broader trend began in California in 1996.
First History: FDA and Endo Pharmaceutical's Opana ER (2017)
When the FDA requested Endo Pharmaceuticals on June 8, 2017 to remove oxymorphone hydrochloride from the market, it was the first demand in the FDA's history.
21st century Reform
Critical Path Initiative
The Critical Path Initiative is an FDA effort to stimulate and facilitate national efforts to modernize science in which FDA-regulated products are developed, evaluated, and produced. The initiative was launched in March 2004, with the release of a report entitled Innovation/Stagnation: Challenges and Opportunities on the Critical Path for New Medical Products.
Patients' right to access unapproved drugs
The New Compassionate Investigative Compassionate Program was created after Randall v. US. decided to support Robert C. Randall in 1978, creating a program for medical marijuana.
The 2006 trial case, Abigail Alliance v. Von Eschenbach, will force radical changes in FDA regulations for unapproved drugs. The Abigail Alliance argues that the FDA should license drugs for use by severely ill patients with "desperate diagnoses," after they complete the Phase I test. The case won an early appeal in May 2006, but the decision was reversed by a March rally 2007. The US Supreme Court refused to hear the case, and the final decision denied the right to an unapproved drug.
Critics of the FDA's regulatory power argue that the FDA takes too long to approve drugs that might ease human pain and suffering more quickly if brought to market faster. The AIDS crisis created some political effort to streamline the approval process. However, these limited reforms are targeted for AIDS drugs, not for the wider market. This led to calls for stronger and longer lasting reforms that would allow patients, under the care of their doctors, access to drugs that have passed the first round of clinical trials.
Post-marketing drug safety monitoring
The widely publicized crack of Vioxx, a non-steroidal anti-inflammatory drug now estimated to have contributed to a fatal heart attack on thousands of Americans, played a strong role in fostering a new wave of safety reforms in both FDA and law-enforcement regulations. Vioxx was approved by the FDA in 1999, and was initially expected to be safer than previous NSAIDs, as the risk of intestinal bleeding reduced. However, a number of pre-and post-marketing studies show that Vioxx may increase the risk of myocardial infarction, and this is convincingly demonstrated by the outcome of the APPROVe trial in 2004.
Faced with various lawsuits, manufacturers voluntarily withdraw them from the market. Example Vioxx has been prominent in the ongoing debate over whether new drugs should be evaluated based on their absolute safety, or their safety relative to existing treatments for certain conditions. After the Vioxx recall, there are widespread calls by major newspapers, medical journals, consumer advocacy organizations, lawmakers, and FDA officials for reforms in FDA procedures for drug safety regulations before and after the market.
In 2006, a committee requested the congress was appointed by the Institute of Medicine to review pharmaceutical safety regulations in the US and to issue recommendations for improvement. The committee consists of 16 experts, including leaders in clinical, economic, biostatistical, legal, public policy research, public health, and allied health professions, as well as former and former executives from the pharmaceutical, hospital, and health insurance industries.. The authors found major deficiencies in the current FDA system to ensure drug safety in the American market. Overall, the authors call for increased regulatory strength, funding, and FDA independence. Several recommendations of the committee have been incorporated into the draft of the PDUFA IV bill, which was signed into law in 2007.
Since 2011, RiskMPS has been created to ensure drug risk never exceeds the benefits of the drug in the post-sale period. This program requires manufacturers to design and implement regular assessments of the effectiveness of their programs. The Minimize Risk Measures Plan is set in place depending on the overall level of risk a prescription drug might pose to the public.
Pediatric drug testing
Before the 1990s, only 20% of all drugs prescribed for children in the United States were tested for safety or efficacy in pediatric populations. This is of particular concern to pediatricians as evidence of the accumulation that the physiologic response of children to many drugs differs significantly from the effects of such drugs in adults. Children react differently to drugs for many reasons, including size, weight, etc. There are several reasons that not many medical experiments are conducted with children. For many drugs, children represent a small proportion of potential markets, that drug manufacturers do not see such testing cost-effective.
Also, since children are perceived to be ethically restricted in their ability to provide informed consent, there are increased government and institutional barriers to approval of this clinical trial, as well as greater concern about legal liability. So, for decades, most of the drugs prescribed for children in the US were done in a way that the FDA did not approve, "off the label," with doses "extrapolated" from adult data through body weight and body surface calculations.
The FDA's initial effort to address this problem was FDA's Final Rules 1994 on Pediatric Labeling and Extrapolation, which allowed manufacturers to add pediatric labeling information, but required untested drugs for pediatric safety and efficacy to bear disclaimers for it. effect. However, this rule failed to motivate many drug companies to conduct additional pediatric drug trials. In 1997, the FDA proposed a rule to require pediatric drug testing from sponsors of the New Drug Application. However, the new regulation was successfully prosecuted in federal court because it exceeds the FDA's legal authority.
While the debate was taking place, Congress adopted the Food and Drug Administration's Modernization Act of 1997 to provide incentives that give pharmaceutical manufacturers a six-month extension of new drugs proposed with child trial data. The reauthorizing action of this provision, the 2002 Best Pharmaceuticals for Children Act, allows the FDA to request NIH-sponsored testing for pediatric drug testing, although this demand is subject to NIH funding constraints. In the 2003 Pediatric Equity Research Equity Act, Congress codified the FDA's authority to mandate manufacturers-sponsored pediatric drug testing for certain drugs as a "last resort" if public-financed incentives and mechanisms proved inadequate.
Priority review coupon (PRV)
The priority review voucher is a provision of the Food and Drug Administration Amendment Act (HR 3580) signed by President George W. Bush signed a bill in September 2007 that awarded "priority review vouchers" to any company approved for care for neglected tropical diseases. The system was first proposed by Duke University faculty, David Ridley, Henry Grabowski, and Jeffrey Moe in the 2006 paper Health Affairs: "Drug Development for Developing Countries". In 2012, President Obama signed the FDA Security Act and the Innovation Act that included Section 908 of the "Voucher Award Program for the Superior of Severe Child Skin Diseases".
Rules for generic biology
Since the 1990s, many successful new drugs for cancer treatment, autoimmune diseases, and other conditions are protein-based biotechnology drugs, regulated by the Center for Biological Evaluation and Research. Many of these drugs are very expensive; for example, Avastin anti-cancer drugs cost $ 55,000 for one year of treatment, while Cerezyme enzyme replacement drug costs $ 200,000 per year, and should be taken by Gaucher's disease for life.
Biotechnology drugs have no simple and easily verifiable conventional chemical structure of drugs, and are produced through complex and often patented techniques, such as transgenic mammalian cell cultures. Because of this complexity, the 1984 Hatch-Waxman Act does not include biology in the New Drug process (YOU), which essentially precludes the possibility of generic drug competition for biotechnology drugs. In February 2007, identical bills were introduced to Parliament to make YOUR process for generic biological approval, but not legalized.
Mobile medical app
In 2013, guidelines are issued to regulate mobile medical applications and protect users from unintentional use. This guide differentiates applications that are subject to the rules based on an app marketing claim. The establishment of guidelines during the development phase of the application has been proposed to accelerate market entry and permits.
Criticism
The FDA has regulatory oversight of a large number of products affecting the health and livelihoods of American citizens. As a result, FDA powers and decisions are carefully monitored by several government and non-governmental organizations. The $ 1.8 million Institute of Medicine report on pharmaceutical regulation in the US found a major deficiency in the current FDA system to ensure drug safety in the American market. Overall, the authors call for increased regulatory strength, funding, and FDA independence.
Nine FDA scientists appealed to President-elect Barack Obama for pressure from management, experienced during George W. Bush's presidency, to manipulate data, including in connection with the review process for medical devices. Characterized as "broken and distorted by current FDA managers, putting Americans at risk," these concerns are also highlighted in the 2006 report on agency as well.
The FDA has also been criticized from the opposite viewpoint, as it is too tough on the industry. According to an analysis published on the Libertarian Mercatus Center website and statements published by concerned economists, medical practitioners and consumers, many feel the FDA goes beyond its regulatory powers and damages small businesses and small farms that support large corporations. Three of the FDA limits under analysis are enabling new drugs and devices, manufacturers' speech controls, and prescription requirements. The authors argue that in an increasingly complex and diverse food market, the FDA is not equipped to adequately regulate or check food. In addition, excessive regulation is blamed for the rising cost of health care and the creation of monopolies, as potential competitors can not get FDA approval to enter the market to compete and lower health care costs.
However, in an indicator that the FDA may be too loose in their approval process, particularly for medical equipment, a 2011 study by Dr. Diana Zuckerman and Paul Brown from the National Research Center for Women and Families; Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, points out that most of the medical devices withdrawn in the last five years due to "serious health problems or deaths" have been previously approved by the FDA using less stringent, and cheaper, 510 (k) process. In some cases the devices are considered low risk so they do not require FDA regulation. Of 113 devices withdrawn, 35 for cardiovascular health purposes.
See also
- The Application of a Drug Efficacy Study
- Food and Drug Administration Modernization Act 1997
- FDA Food Safety Modernization Act 2011
- FDA's Fast Track Development Program (for medicines)
- Food and Drug Administration Amendment Law 2007 (eg medicines)
- The 2012 Food and Drug Administration's Safety and Innovation Act (GAIN/QIDP etc.)
- The benefit law is reversed
- Investigational Device Exemption (for use in clinical trials)
- Kefauver Harris Amendment 1962 - Requires "proof-to-efficacy" for drugs
General:
- Adverse reactions
- Adverse events
- Adverse drug reactions
International:
- Food Administration
- International Conference on Harmonization of Technical Requirements for Pharmaceutical Registration for Human Use (ICH)
- Brazil: National Health Supervisory Agency
- Canada: Directorate of Health Products Marketed
- Canada: Canada Health
- Denmark: Danish Drug Agency
- The European Union: The European Medicines Agency
- Germany: Federal Institute for Medicines and Medical Devices
- India: Food Safety and Indian Standards Authority
- India: Standard Medicines Control Organization
- Japan: Ministry of Health, Labor and Welfare (MHLW)
- Japan: Pharmaceutical Agents and Medical Devices
- Mexico: Federal Commission for the Protection of Sanitary Risk
- United Kingdom: Agency for Drug and Health Products Control
- United States: Food and Drug Administration
References
Note
Further reading
- Givel, Michael (December 2005). "Philip Morris FDA Picture: Good for Public Health?" Journal of Public Health Policy (26): pp.Ã, 450-468
- Henninger, Daniel (2002). "Drug Lag". In David R. Henderson (ed.). Economic Concise Encyclopedia (1st ed.). Library of Economy and Freedom. < span> Ã, CS1 maint: additional Text: list editor (link) OCLCÃ, 317 650 570, 50.01627 million, 163 149 563
- Hilts, Philip J. (2003). Protecting American Health: FDA, Business, and Hundred Years of Rules. New York: Alfred E. Knopf. ISBNÃ, 0-375-40466-X
- Kevin Fain, Matthew Daubresse, G. Caleb Alexander (2013). "Food and Drug Administration Amendment Law and Post-Market Commitment." "JAMA" 310 (2): 202-204 doi: 10.1001/jama.2013.7900.
- Madden, Bartley (2010) Free to Choose Treatment: How Faster Access to New Drugs Would Save Lives and End Suffering Number of Unnecessary Chicago: The Heartland Institute. ISBN: 978-1-934791-32-5
- Moore, Thomas J. (1998). Recipe for Disaster: Hidden Dangers in Your Drug Wardrobe. New York: Simon & amp; Schuster. ISBNÃ, 0-684-82998-3
- Obenchain, Janel, and Arlene Spark. Food Policy: Looking Ahead from the Past. Press CRC, 2015.
External links
- Official website
- Food and Drug Administration in the Federal List
- FDA Organization Hierarchy Chart in PDF format
- Strategic Plan
Source of the article : Wikipedia
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