Approval Essay, Research Paper
The United Sates Food and Drug Administration has been protecting American consumers for around 70 years. The FDA assures the safety drugs, medical devices, chemicals, cosmetics, foods and additives by evaluating products for approval. Controversy has recently been surrounding the FDA’s drug approval process, due to a general trend to get pharmaceuticals on the market more quickly. The FDA has been under pressure from congress and the public to speed approval, but pharmaceutical companies, who benefit more than anyone form accelerated drug approval, have also been applying pressure to the FDA through congress. The speeding of the approval process helps patients with incurable illnesses receive experimental drugs, but some wonder if the FDA is weakening its safeguards in the process. Since the passing of the Modernization Act last year, people have become concerned with the safety of dietary supplements and ‘off-label’ uses for drugs. In the past year, drugs have been approved at an unprecedented rate, but they also have been withdrawn from the market more frequently. The recent growth in the popularity of dietary supplements has caused many to worry about their safety. Thus, there remains the question if the FDA is still adequately protecting us from dangerous drugs.
The Food and Drug Administration began in the U.S. in 1927 as a separate law enforcement agency and now employs over 9,000 workers spread over 157 cities (The Food and Drug Administration: An Overview 1). Four laws dictate the power of the FDA. The Federal Food, Drug and Cosmetic Act established purity standards and introduced the requirement of factory inspection. The FDA’s authority to require honest informative and standardized drug and device labels was established by The Fair Packaging and Labeling Act. The Radiation Control for Health and Safety Act guarantees consumers protection from excess radiation in certain devices. Lastly, The Public Health Service Act expanded the FDA’s authority to cover serums and vaccines and also justified the inspections of restaurants (Food and Drug Administration [Britannica]). The FDA is adjusting to a switch in leader ship since Jane Heney, previously the FDA’s deputy commissioner of operations, was nominated in June 1998. Heney, the first woman to head the FDA, has a packed resume that includes a vice presidency of the University of New Mexico and a specialization in cancer research. Her strategy for the future of the FDA includes the enforcement of new federal laws to modernize the FDA and addressing concerns about drug safety and approval speed, as well as controlling food contamination (Davis 5D).
The FDA requires pharmaceutical companies to conduct years of research on their drugs before they begin the actual process approval. Drug companies submit test results to the FDA to be reviewed by their scientists; the FDA actually does no preliminary research on the drugs. In order to be approved, the companies must prove to the FDA that each drug is safe and effective and that the benefits of the drug must outweigh its side effects. The FDA has 800 to 900 employees involved in reviewing drugs before they get to the market. After a drug is approved, the FDA researches by collecting and analyzing thousands of reports each year. Large teams of investigators review drugs to see if any may need to be withdrawn from the market by looking for unexpected and adverse reactions (An Overview 2).
The entire procedure of research to which pharmaceutical companies must subject their drugs consists of three phases. In the Pre-Clinical Stage, companies must screen their synthetic chemicals for potential use by performing studies in test tubes and with animals. After around two years of testing, companies usually file an Investigational New Drug Application (IND) with the FDA. Next, in the Clinical Stage, drug companies spend around eight years conducting studies on healthy humans and large groups of clinical patients. When enough research is conducted on a drug, a company can file a New Drug Application (NDA) to the FDA for approval review. The third and final stage is the actual process of the FDA’s approval for marketing. In the past, the process took an average of 3 years to review a drug, but certain drugs with high potential and demand could receive approval in under a year (Ballance 93). Now, many drugs are being approved in as little as 6 to ten months.
Over the last 6 years, the FDA has been making an effort to speed the approval process with new acts and amendments designed to get drugs on the market quicker. Many of the reformations to the approval process pertain to drugs for patients with serious or life-threatening illnesses such as Alzheimer’s, cancer and AIDS. While these modifications help many people receive new and experimental drugs that could significantly help their conditions, the FDA claims that they have safeguards ensuring that the approval process isn’t compromised. One new procedure, Treatment IND, provides approval when there is no effective alternative treatment. This has allowed many new AIDS drugs into the market. Parallel Track approval makes new drugs for treating HIV-related diseases available to patients who are unable to take standard therapy. With Parallel Track, patients are given the option to agree to take experimental drugs. The FDA can approve a drug on “surrogate endpoints” with Accelerated Approval. Promising lab tests and physical signs of clinical benefit can serve as grounds for approval with this procedure, which has allowed many AIDS drugs to be approved. Safety Testing Harmonization allows the FDA to accept safety testing on animals conducted in Japan and a handful of European Countries. If companies can accept tests from international companies, they eliminate duplicate reviews, cutting time off the approval process. In addition, the FDA now allows qualified experts outside the government to review certain routine applications with the act of Outside Expert Reviews. Distributing the workload reduces the buildup of NDAs the FDA must review each year (FDA Highlights: Speeding Approval 1).
But what has caused the FDA to speed up its approval process? Both the public and physicians have been putting pressure on the FDA to quicken drug approval, but congress’s influence has been immense as well. Republicans have been pushing for amendments to the FDA’s regulatory review policies since they took control of congress in 1994. Though the congress justifies its pressure for a faster approval process by claiming that many patients are suffering and dying while they wait for important drugs to be approved, it seems that they actually have put corporate profits and special interests above the wellbeing of the public (Lewis 144). A swifter approval process helps drug companies get their products on the market faster, which helps them start making big profits sooner. So why does congress seem interested in helping drug companies? The answer all comes down to money. Though the FDA has been trying to find ways to increase their funds through acts like the recently renewed Prescription Drug User Fee Act, which allows the FDA to collect fees from drug companies to help speed the application process, congress has had more than enough financial support from drug manufacturers. Over the last decade, the drug industry has given congress campaign contributions totaling around $28 million (Lewis 146). Many of the legislators on Capitol Hill that are the most critical of the FDA have received a substantial amount of money from pharmaceutical companies. In addition, a number of drug companies have paid for some of the campaign and convention expenses of certain congressmen. It is not unusual for some politicians to be flown around the country in planes owned by drug companies, while other drug companies sometimes pick up the tab of large political receptions. According to public filings, drug companies and organizations spent more that $41 million to influence congress in 1996 (Lewis 147).
In November 1997, the FDA Modernization Act of 1997 was passed in cooperation with Vice President Al Gore’s Reinventing Government Program. The act, which focuses on reforming the regulation of food and medical products, provided for a number of different modifications, including the reauthorization of the Prescription Drug User Fee Act of 1992 (mentioned above), which helped to reduce the average 30 month process of drug review (Lewis 151). The Modernization Act also introduced advancements designed to accelerate the certification, approval and regulation of drugs. In addition to accelerating the review of important new medications, the act describes the FDA’s wishes to increase patient access to experimental drugs and medical devices. Although the FDA claims that they are not lower the standards by which pharmaceutical products are introduced to the market, the Modernization Act allows for one clinical investigation to serve as the basis for approval in certain situations. However, the general rule remains that two adequate and well-controlled studies are needed to prove the product’s safety and effectiveness (FDA Modernization Act of 1997 2). Many people protest that the Modernization Act significantly affects the ability of the FDA to safeguard drugs, especially concerning the continued acceptance of ‘off-label’ uses for drugs.
Off-label use allows approved drugs to be prescribed for unapproved uses, which can include the combination of drugs. Off-label uses for drugs haven’t acquired enough substantial evidence to deem them worthy of approval. However, the FDA has no authority over physicians, who can legally prescribe any approved drug for any use they see fit. The only regulation of off-label uses for drugs is a requirement that gives drug companies a certain time period to submit a supplemental application based on appropriate research to show that the unapproved use is safe and effective. Today, more than 100 million Americans take medications that were not intended for their ailments (Lewis 144). If the FDA approves a drug, it must be safe and effective, but they cannot possibly consider all uses. By not applying for approval of an off-label use, pharmaceutical companies do not have to spend millions of dollars on clinical trials or safety research, which allows them to keep more profits from an old drug (Lewis 153). In September 1997, the FDA recalled the drug fenfluramine after it had been widely prescribed with another drug as an off-label use, commonly referred to as fen-phen (a combination of fenfluramine and phentermine). The combination of the drugs has been found to often cause heart complications, and it lead to at least 70 deaths between 1974 and 1997. Doctors wrote millions of prescriptions for fen-phen without always giving a preliminary physical exam (Kerr 1). Though the drugs were really meant for those who needed to lose weight because of health risks, the off-label prescription was often given to those just looking to trim some pounds off. Now, the off-label combination of these drugs is unapproved but still legal. Pharmaceutical companies are currently urging congress to pass a law that would immunize them from any punitive damages if they sold their FDA-approved drugs for off-label uses (Hellmich 1A). This would create obvious problems for people taking drugs for off-label uses that could potentially be dangerous. Some say that this could lead to drug companies scamming the system, leading to more off-label catastrophes while they perform flawed studies and bury the unflattering reports. On the other hand, many off-label drug uses are extremely beneficial. Over 40% of all cancer drugs are prescribed off-label. In addition, Aspirin is widely used to help heart disease, and pediatric patients often receive off-label prescriptions (FDA reforms healthy 14A).
It is estimated that 80% of prescription drugs given to children are not tested to see if they are safe for young users. Pediatricians have been forced to guess the proper dosages, even though children react to and metabolize drugs differently than adults (Lewis 145). The FDA has offered incentive to drug companies in the past to seek pediatric labeling approval of their drugs, but few of the companies bothered. Only 20% of the drugs licensed by the FDA since 1962 have been approved for children (Lewis 155). The pharmaceutical companies would rather not test their drugs on children because of a number of risks and added expenses (a controlled drug study costs a company about $30,000 per participating child!). Now the FDA has made modifications that will ensure the safety of drugs given to children. The Clinton Administration passed a bill in November 1998 that requires companies to test their drugs on children if they expect them to be taken by more than 100,000 young patients a year (Pear 1A). The FDA has the power to enforce this new requirement by suing drug companies and seeking fines from them for noncompliance, but they do not have the power to remove the drugs from the market. It is estimated that these new requirements for testing drugs on children will cost the drug industry $13.5 million to $21 million a year. However, this price should not mean much for the drug industry, which generates more than $60 billion a year in U.S. sales alone (Lewis 157).
Today the process of FDA drug approval is so accelerated that drugs are entering the market at an unprecedented rate. The average period of time for FDA review dropped from 30 months in 1992 to 15 months in 1997. The approval time for brand-new drugs averaged about 15 months in 1996 and dropped to 12 months in 1997. The FDA approved 121 drugs in 1997; a considerable amount compared to the 69 drugs approved in 1987. In the future, the FDA will take an average of 10 months to approve standard drugs and six months to approve priority drugs (Levy 17A). On the downside, this recent speedy approval process has caused the FDA to withdraw a significant number of drugs from the market. Sometimes dangerous drugs reach the market because there is no way of answering every question of safety. Doctors sometimes ignore warnings that come with drugs, as in the case of Duract (a painkiller withdrawn last year). Warnings were posted with the approval of Duract stating that it should never be prescribed for more than ten days, but many users suffered from side effects after they had been taking the drug too long. Even though Duract was only on the market for 11 months, doctors wrote 2.5 million prescriptions for it, and many did not heed the warnings (Rubin 1A). In the last three years, more drugs than ever have been approved, and more drugs than ever have been taken off the market. Between September 1997 and July 1998, the FDA withdrew five drugs from the market, after it had not withdrawn a drug since 1992 (Rubin 1A). To protect the public and still get drugs to the market quickly, the FDA must focus on enhancing drug safety requirements as much as on speeding approvals by increasing pre-approval testing and post-marketing monitoring. Efficient approval of new drugs is very promising for patients today, but the process must not short-cut safety.
The recent fever over dietary supplements has raised concerns with many consumers and the government. Dietary supplements are pills, capsules and extracts from sources such as Chinese herbs and shark cartilage that are used to treat all sorts of ailments. These supplements can go on sale without any evidence that they work, even though some of them have been reported to be dangerous. In 1994, a law was passed to remove supplements from the strict controls of drugs and food. The dietary supplement industry is thriving because there are virtually no regulations for them, and they are producing around $6.5 billion a year (O’Donnel 1A). Though the White House has been recommending tighter regulation of dietary supplement labels in the last year, the FDA has been having trouble ensuring the safety of the products. In order for any of the supplements to be pulled off the market, the FDA must prove that the supplement poses an “imminent hazard” to public safety. While supplement sellers, users and companies say the ‘imminent hazard’ rule is enough power for the FDA to have to keep unsafe supplements off the market, the FDA has still has not taken any actions to control any supplement (O’Donnel 1A). Supplement manufacturers are reaping the benefits of avoiding the approval process. Developing dietary supplements costs a fraction of the money it takes to develop a drug, and it only takes around two years for them to reach the market. It is important to understand that any while chemical or herb is toxic at some level, it is unknown just at what level any supplement becomes toxic because the necessary test were not required to be performed (O’Donnel 1A). One can only speculate what lies ahead for the impact of dietary supplements on the health of the public.
In the past, the FDA has strictly enforced the requirement for drugs to be safe and effective. However, pressure on congress from pharmaceutical companies has caused the government to initiate restrictions on the FDA’s approval process. While many suffering patients are benefiting from the greatly increased speed of the approval process, many others are wondering if their safety is being jeopardized. The public must become aware of the fact that large companies’ desires for big profits could be putting consumers at risk. Prescription drugs are meant to treat and cure illnesses, and it is important that they do not endanger lives.
Balance, Robert. The World’s Pharmaceutical Industries. Hants, England: Edward Elgar
Pub. Ltd., 1992.
Davis, Robert. “Woman nominated to head FDA.” USA Today 24 June. 1998: 5D.
Editorial. “FDA reforms healthy.” USA Today 28 Sept. 1997: 14A.
Encyclopedia Britannica Online. Food and Drug Administration. 30 Sept. 1998
Food and Drug Administration. FDA Highlights: Speeding Approval/Expanding Access.
9 March. 1995. 30 Sept. 1998 .
Food and Drug Administration. The FDA Modernization Act of 1997. 21 Nov. 1997. 24
Nov. 1998 .
Food and Drug Administration. The Food and Drug Administration: An Overview. 30
Sept. 1998 .
Hellmich, Nanci and Steve Sternberg. “Where the buck stops: Critics say known side
effects were enough to stop approval.” USA Today 16 Sept. 1997: 1A+.
Kerr, Kathleen. “FDA knew of fen-phen woes years ago.” Detroit News 19 Oct. 1997:
Levy, Doug. “FDA role key in new drug direction.” USA Today 24 Nov. 1998: 17A.
Lewis, Charles. The Buying of Congress. New York: Avon Books, 1998.
O’Donnel, Jayne. “Neither Food nor Drug.” USA Today 19 June. 1997: 1A+.
Pear, Robert. “FDA will require companies to test drugs on children.” New York Times
28 Nov. 1998: 1A+.
Rubin, Rita. “Rush to judgement? Policy speeds approvals, but some say it’s risky.”
USA Today 10 July. 1998: 1A+.