The Controversy Behind How Drugs are Regulated in the U.S.

The United States Food and Drug Administration (FDA)’s most prominent role is evaluating new drugs before they can be sold legally.

The FDA’s Center for Drug Evaluation and Research (CDER) evaluates drugs to prevent quackery and to give doctors and patients information necessary to use medications appropriately. CDER makes sure that name-brand and generic drugs work as they are supposed to and that their health benefits outweigh known risks.

Companies that want to sell a drug in the US have to test it and submit evidence to CDER showing that the drug is safe and effective for its intended use. CDER physicians, pharmacologists, chemists, and mathematicians review the company’s data and labeling proposal. If CDER establishes that the drug’s benefits outweigh known risks, the drug is approved for sale.

Criticism of the FDA falls in to four major categories:

• Allegations that the FDA takes too long to approve drugs
• Allegations that the FDA approves drugs too hastily
• Criticism that the FDA has excessive regulatory authority
• Criticism that the FDA has insufficient regulatory authority

Allegations That The FDA Takes Too Long To Approve Drugs

Concerns over lengthy drug approval processes gained media attention in the late 1980s and 1990s when AIDS activists alleged that thousands of lives were lost every year because of delays in approval of new drugs. In 1962, the average time from filing an application for approval from the FDA until approval was seven months. By 1998, the average time from application to approval was 7.3 years. The FDA has introduced expedited approval procedures for drugs used to treat life-threatening conditions, and they have expanded pre-approval access to drugs for patients who have limited treatment options.

Allegations That The FDA Approves Drugs Too Hastily

Under the FDA’s “Expedited Drug Development Pathway,” the FDA is able to hasten approval for promising drugs made for life-threatening conditions, particularly in cases where other drug options are limited or nonexistent. Three drugs approved under this program were vandetanib (for late stage thyroid cancer), fingolimod (for multiple sclerosis, and dabigatran (for prevention of stroke). A September, 2012 article in the Journal of the American Medical Association called this program into question because of known safety risks of all three medications.

The FDA has also been the recipient of criticism in its approval process for medical devices, including an all-metal hip replacement implant, surgical mesh implants that repair faulty heart valves, and leads on implanted defibrillators. These allegations target an FDA clearance process called 510(k), which doesn’t require clinical data if manufacturers can show that a new device is “substantially equivalent” to a previously approved device on the market.

Criticism that the FDA Has Excessive Regulatory Authority

Some critics, including economist Milton Friedman, say that the FDA’s regulatory process is biased against approval of worthy drugs, because the consequences of mistakenly approving a harmful drug include widespread condemnation of the FDA. The result, say Friedman and like-minded critics, is that the FDA inherently takes actions that result in the least risk of public condemnation, even if lives could be saved had the FDA approved the drugs.

Criticism that the FDA Is Insufficiently Regulated

Other critics say that the FDA is too willing to overlook safety problems and is too slow to withdraw approved drugs when they’re shown to be unsafe. Perhaps the highest profile example is Vioxx, an anti-inflammatory drug that was pulled from the market in 2004 by the manufacturer. Vioxx pre-approval studies indicated a four-times-higher risk of heart attack compared to patients taking naproxen, another anti-inflammatory. Vioxx’s manufacturer argued that the perceived increased risk of Vioxx had to do with a cardio-protective effect of naproxen rather than increased risk with Vioxx. Later random, placebo-controlled studies confirmed a higher risk of heart attack with Vioxx, and the manufacturer pulled the product after facing numerous lawsuits.

How The FDA and Government Are Responding to Criticism

The Prescription Drug User Fee Act (PDUFA), was first enacted in 1992 and has been renewed every five years since. It allows the FDA to collect fees from manufacturers of original human drug and biological products. The FDA uses the money to “expedite and improve the review of human drug applications.” The latest renewal of PDUFA, in July 2012, adds an additional $40.4 million in new user fees, bringing the FY2013 collected total under PDUFA to $712.8 million. Since 2007, the FDA has been allowed to allocate some fees collected under PDUFA toward monitoring adverse events in the first two to three years that a new drug is on the market.

Of the $4.7 billion in FDA funding proposed in President Obama’s latest budget proposal, $2.6 billion was appropriated by Congress, with the rest coming from new user fees. Additional funding over the 2012 baseline will go to new programs, including a $10 million program to improve oversight of medical imports into the US (since 80% of ingredients used in drugs manufactured in the US come from other countries), as well as regulatory science initiatives that are supposed to promote safe and effective products and expedite the regulatory approval process.

The FDA has long been a target of criticism from many directions, but if anything, competing criticisms have had the effect of preventing the FDA from making sweeping changes in any direction. Don’t look for criticism of the FDA to die down from any side any time soon.

Photo Credits: U.S. Food and Drug Administration, arztsamui / freedigitalphotos.net, Stuart Miles / freedigitalphotos.net