The Politics And Economics Of Fda Drug

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 In the past year, drugs have been approved at an unprecedented rate, but they also have been withdrawn from the market more frequently.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 Acceler