Issue Brief
February 28, 2003
The Food and Drug Administration: Where Has it Been? Where is it Going?
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Issue Brief February 28, 2003 The Food and Drug Administration: Where Has it Been? Where is it Going? |
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"From the beginning of civilization people have been concerned about the quality and safety of foods and medicines." Milestones in U.S. Food and Drug Law History, U.S. Food and Drug Administration
Introduction Last April, the United States Supreme Court issued a stinging rebuke to the Food and Drug Administration (FDA) in response to its restrictions on advertising of certain commercial drugs. The court ruled that the FDA violated First Amendment free speech protections in the case Thompson v. Western States Medical Center. This is not the first case the FDA has lost in recent years. The agency is now in a major review process to determine how it can continue to meet its obligations to protect public health while at the same time not violating the free speech guarantees of the constitution. While some maintain that this is just a new form of deregulation through the courts, there is no doubt that there is a fundamental tension between some aspects of FDA's authority and case law on the first amendment. The questions today are what is the appropriate role for the FDA in the 21st century, and how can it fill that role without running afoul of the Constitution?
The Food and Drug AdministrationRecent new accounts of contaminated blood in Nashville and Atlanta remind us of the importance of vigilant consumer regulatory agencies. The FDA is one of the oldest consumer regulatory agencies in the federal government and it has very broad responsibilities for the public's health. Along with being responsible for the safety of the nation's blood supply and other biologics (i.e. substances such as vaccines), it is responsible for the safety of prescription drugs, medical devices, cosmetics, electronic products such as microwave ovens and cell phones, and 80 percent of the nation's food supply. Today the agency has more than 9000 public health employees and it makes decisions that affect every person in the country every day. In the year 2000, consumers spent $1 trillion on products that are directly regulated by the FDA. In September 2002, President Bush named Dr. Mark McClellan as his choice to head the FDA. Dr. McClellan has rejected a narrow view of the role of the agency saying "There has never been a time in the history of the FDA when we have had either more challenges or more opportunities for meeting those challenges." Within the broad mission of the agency he wants to focus on three priorities.
While these FDA goals are uncontroversial, there is considerable controversy over the implementation of those goals. To understand how this agency fits in today's world, it is helpful to review its history.
History of the FDA From colonial times to today, the challenge of ensuring safety in the food and medicine used by the American people has been filled with tension. In its earliest times, the U.S. colonies had regulations concerning bread and meat, and the first national law in this arena was the Drug Importation Act, passed in 1848. It banned the importation of adulterated drugs and required the U.S. Customs Service to stop the entry of adulterated drugs from overseas. 1. The
1906 Federal Food and Drug Act and the "Poison Squad" The most significant act, however, for the modern era was the Federal Food and Drugs Act passed by Congress on June 29, 1906 and signed by President Teddy Roosevelt one day later. Prior to this time the Bureau of Chemistry—the precursor to the FDA—had only research responsibilities. The 1906 act added regulatory functions to the agency's responsibilities. As with other major regulatory legislation, the passage of this act was precipitated by a crisis. Although several broad regulatory bills had been introduced over the years and twice an omnibus bill had passed the House of Representatives, a variety of forces kept the bills from becoming law. Advocates for the law, under the direction of Dr. Harvey Wiley, the chief chemist in the Bureau of Chemistry, even went so far as to set up a "Poison Squad.” This was a group of able-bodied government employees who volunteered to consume varying amounts of adulterated foods to determine the impact on their health. While they drew a lot of publicity, even that did not get a law passed. Then in 1906 Upton Sinclair wrote his famous novel, The Jungle, exposing the sordid and filthy conditions in Chicago's meat packing industry. The catastrophe that precipitated the 1906 act concerned meat. During the Spanish-American War, American troops became sick from eating tainted meat. When packers were blamed for shipping "embalmed beef" to the troops, it was easily believed in light of the information exposed in The Jungle. That book proved to be a precipitating force behind both a meat inspection law and a comprehensive food and drug law. The act prohibited the interstate transport of unlawful food and drugs under penalty of seizure and prosecution of the responsible parties. The basis of the act rested on the regulation of product labeling rather than pre-market approval. Drugs were defined in accordance with standards of strength, quality, and purity set in the United States Pharmacopoeia and the National Formulary. Any variations from those standards had to be plainly stated on the label. Foods did not have analogous standards but the law prohibited the additions of ingredients that "would substitute for food, conceal damage, pose a health hazard, or constitute a filthy or decomposed substance." Food and drug labels could not be false or misleading in any detail. And there was a list of eleven dangerous ingredients such as alcohol, heroin, and cocaine whose presence and amount had to be shown. These provisions led to some very long and protracted court battles. In the beginning, officials administering the law placed the greatest emphasis on food because they believed tainted food was the most serious health threat to the American people. Later, however, the bureau devoted more efforts to drug regulation particularly the patent medicines that were so common at the time.
2. The 1938 Food, Drug, and Cosmetic Act As time went by the 1906 Act proved to be inadequate and in 1938, again precipitated by a crisis, major revisions and expansions were added to the law. The crisis this time was a therapeutic disaster in 1937 in which a Tennessee drug company marketed a new wonder drug for pediatric patients. Unfortunately, this untested product was highly toxic and more than 100 people died, many of them children. The public outcry over this catastrophe reshaped the drug provisions of the law and actually pushed the change through Congress. The new law did several things but one major shift was the mandate for pre-market approval of all drugs. Every manufacturer would have to prove to the FDA that a drug was safe before it could be sold. The 1938 Act brought regulation of cosmetic and therapeutic devices under the law and required that drugs be labeled with adequate directions for safe use. It also corrected certain abuses in food packaging and quality, set safe tolerances for certain unavoidable poisonous substances, authorized factory inspections and added the remedy of injunctions to other enforcement tools already in law.
3. Subsequent Acts There have been several changes to the law since 1983 with some being more critical than others. One critical change was in the 1962 Kefauver-Harris Drug Amendments that were inspired by the thalidomide tragedy in Europe. This change required that drug manufacturers prove the efficacy as well as safety of their products before marketing them. It also moved authority over promotion and advertising of prescription drugs from the FTC to the FDA. In the Medical Device Amendments of 1976, the
law was changed to ensure the safety and effectiveness of medical devices.
This change was in direct response to a U.S. Senate finding that faulty
medical devices had caused 10,000 injuries, including 731 deaths. In 1984, the Hatch-Waxman amendments to the Food, Drug and Cosmetic Act provided a process for improving the availability of lower-priced generic drugs. This law, officially named the Drug Price Competition and Patent Term Restoration Act of 1984, was intended to balance two important public policy goals. The first of these goals is to ensure that drug manufacturers have enough market protection to encourage the development of innovative new drugs. And the second goal is to ensure that once the necessary patent protection has expired, consumers can benefit from a rapid approval of lower priced generic versions of those drugs. While these goals can sometimes be in conflict, they are both important in health policy, and the FDA has the critical role of balancing them. In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). This law provided for the collection of industry user fees to add resources to the FDA for the process of reviewing new drugs. Last year, this practice was expanded to include medical devices. In the Medical Device User Fee and Modernization Act of 2002, Congress authorized a device user fee program aimed at speeding up the process of approving new medical devices. The law also authorized third party inspections. This practice is still controversial in some circles as many consumer advocates argue that it creates an inherent conflict of interest when the agency regulating a product receives its resources from the manufacturer of the product. The most wide-reaching change in several decades, however, is found in the Food and Drug Administration Modernization Act of 1997 (FDAMA). This law included wide-ranging changes in agency practices. It is most known for its stringent requirements to speed up agency review of medical devices and new drugs. It also included provisions to regulate health claims for food and the advertising of unapproved uses of approved drugs. And perhaps one of its most lauded provisions is section 111, the Better Pharmaceuticals for Children Act also known as the pediatric exclusivity rule. This law provides an incentive to industry by giving brand companies an additional six months of market exclusivity in exchange for rigorous clinical studies of the effect of any new drug on children. In January 2001, the FDA reported to Congress "...this provision has done more to generate clinical studies and useful prescribing information for the pediatric population than any other regulatory or legislative process to date."
Challenges As the introduction noted, recent court cases have made the FDA more aware of the tensions in its mission. Today it faces many challenges. What are these challenges and what does the agency plan to do about them? 1. The first amendment and direct-to-consumer (DTC) advertising. Although the FDA has had authority over drug advertising and promotion since 1963, prior to the 1980s prescription products were not promoted directly to consumers and patients. In the early 1980s, however, some manufacturers started to advertise their products directly to consumers and the FDA started to evaluate the practice. These promotions were confined largely to the print media. Gradually this practice began to change and in 1997 the agency issued temporary guidance for advertising in the broadcast media, which it finalized in 1999. As anyone who watches the evening news knows, the advertising of prescription drugs on television has taken off dramatically since that time. The FDA has lost a series of court challenges to its regulations governing DTC advertising. The courts have become increasingly aggressive about protecting "commercial speech" in the last few years and more than once they have ruled against FDA regulations as violating the first amendment. The FDA has recently begun a review of its operations to see what it can do to bring its procedures in line with the Constitution as the courts have recently interpreted it. 2. Improving the safety and effectiveness of drugs used for children. Since children are subject to most of the same diseases that afflict adults, it is important to have a better understanding of how drugs affect them. What is safe for an adult may be extremely harmful to children and it is essential to understand the effects of treatments on children. Although the pediatric exclusivity provision was reauthorized by Congress last year and continues to be useful in providing new pediatric therapies, another critical rule that benefited children was struck down by the courts. In 1998, after Congress had provided an incentive for drug companies to test their products on children through the pediatric exclusivity provision, the FDA added its own "pediatric rule" which allowed it to require pediatric testing of any drug used frequently by children. This rule in tandem with pediatric exclusivity encouraged great advances in the development of new knowledge about drug effects on children. Many advocates maintain that together these provisions were more successful than either one could have been alone. A private doctors group and a conservative think tank, however, did not agree with this provision and challenged it in court. In October of 2002, the federal judge hearing the challenge agreed with the doctors and ruled that Congress had specifically refused to require drug testing in children when it passed legislation giving the industry financial incentives for that purpose. The judge stated that FDA had overreached its authority by requiring such tests. The Bush Administration has
decided not to appeal that decision. Rather, FDA Commissioner Dr. Mark
McClellan has said he will work with Congress to get legislation giving
FDA the authority to require pediatric testing. He believes that this will
resolve the issue more quickly than trying to fight for the rule in the
courts. 3. Generic Drugs. The ongoing need to innovate in medicine and the need to manage the spiraling costs of health care come together in the FDA's management of the Hatch-Waxman Act to improve access to generic drugs. The FDA has been besieged with challenges in managing this process. Last fall President Bush announced a new regulation that is intended to speed up the introduction of generic drugs. In his announcement he said “...Unfortunately, the careful balance of the law is being undermined” and he cited an FTC study that indicated “some brand name drug manufacturers may have manipulated the law to delay the approval of competing generic drugs.” The new regulation would limit the amount of time drug manufacturers could delay a generic drug maker's application to produce a competing drug. It also tightens the rules for new patents. Secretary Thompson of the Department of Health and Human Services believes the new regulation could save consumers about $3.5 billion a year. 4. Herbal Medicines and Food Supplements. The role of the FDA in ensuring the safety of herbal medicines has been limited by a law passed in 1994. This law, the Dietary and Supplemental Health and Education Act, classified herbs as dietary supplements and removed the requirement that manufacturers provide the FDA with evidence that a product is safe before marketing. While the FDA has the power to require manufacturers to report to the agency about all adverse effects from their drugs, it does not have that power with regard to dietary supplements. Dr. Mark McClellan has warned the dietary supplement industry that he will crack down on companies making fraudulent health claims but the law does not favor him in this endeavor. While he can get the drug industry to report their problems to him when it comes to herbal medicines and dietary supplements, the FDA must prove after the fact that the substance is dangerous. Since, it lacks the staff and resources to track down all these problems, consumers are often exposed to very dangerous substances with little warning. This is an area where the agency needs to work with Congress to provide more safeguards to consumers. 5. The “Moral Issues” and Terrorism. Recent advancements in the biologic sciences present new challenges. In 1998, the FDA asserted its authority over cloning. The agency considers embryos created in the cloning process to be biologic products and therefore subject to its regulation. Some question this view and it will, no doubt, be challenged as more work is done in the area. After September 11, 2001, the FDA has been charged with two critical functions in the fight against terrorism. First, it has been given the responsibility to prevent the willful contamination of all regulated products including food and secondly, it has been asked to help improve the availability of medications to prevent or treat injuries caused by biological chemical or nuclear agents. As he has stated, Dr. McClellan has taken this charge very seriously and lists it as his number one priority within the overall mission of the agency. Clearly, these two new charges along with the ongoing work of the agency will require more resources.
ConclusionThe FDA is entering the 21st century with major challenges before it. While it has come a long way from the days when a "Poison Squad" was needed to demonstrate the need for consumer protection from tainted foods, there is a mood for deregulation in many aspects of American life. At the same time technological advances and the complexity of modern life make everyone more vulnerable. Most Americans count on the FDA to ensure that their food is safe, their cosmetics won't harm them, the blood they need for a transfusion won't make them sick, and their drugs do what the manufacturers say they will do. It is essential that the FDA find a way to meet its mission that does not run afoul of the Constitution and other laws so that people can be truly protected to the full extent of the law. And, if the law isn't adequate, the people can lobby their elected representatives for remedies. It is also critical that the President and Congress provide enough money and support so that this important agency can fulfill its mission for the American public.
Author This Issue Brief was written by Eileen Baumgartner, NIHP Senior Researcher and former Democratic Staff Director of the House Budget Committee.
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