FDA Under Pressure: How Big Pharmaceutical Companies Influence New Drug Review

The Food & Drug Administration (FDA) pulled Darvon and Darvocet off the market last year because of the safety risks they pose to the human heart. The drugs were approved in 1957 for the treatment of mild to moderate pain, but when safety concerns were presented to the FDA in 1978 and again in 2006, they were largely ignored.

In fact, in 2009 the FDA heard evidence from one of its own committees that Darvon and Darvocet had been linked to thousands of deaths and that their risks outweighed any benefits the drugs may have had for the treatment of pain. Yet, the FDA refused to pull the drugs off the market, and instead required that their manufacturer, Xanodyne, issue a stronger warning about the drugs' side effects. Less than two years later, the FDA finally decided to recall the drugs, citing the unreasonable risks they pose to consumers.

Realizing the fatal toxicity danger the drugs posed, the United Kingdom banned Darvon and Darvocet in 2005. Meanwhile, the United States continued to allow the drug to be sold. From the time the United Kingdom pulled the drugs up to the time the United States pulled the drugs, Public Citizen (an advocacy group for citizens' rights) estimates that an additional 1,000 to 2,000 Americans died from complications associated with taking the drugs.

Scenarios like this beg the question, is the FDA broken?

Some critics argue that the FDA is far too prone to approving drugs not yet found to be safe for approval because of the influence the major pharmaceutical companies and their lobbyists have over the agency. Lobbyists have long had a powerful influence over certain actions taken by the FDA. For instance, with the Prescription Drug User Fee Act of 1992 (PDUFA), the pharmaceutical industry was allowed to pay into the system to help speed up the approval process for new drugs. This sharply reduced the approval time from an average of 30 months in 1992 to just 16 months in 1996 (source: Frontline). While this trend is reversing, some argue the FDA should continue to monitor a drug after it has been approved, especially since most side effects are seen within seven years of being on the market.

The one area where the FDA has remained fairly strict against the pharmaceutical industry is in marketing. Drug manufacturers are not allowed to market drugs for off-label, non-FDA approved uses. In fact, just recently Novartis Pharmaceuticals paid a fine of $420 million after the company pleaded guilty to illegally marketing one of its prescriptions.

Unfortunately, the one area where the FDA has had trouble policing pharmaceutical companies is in manufacturing standards. Because the FDA does not have the resources necessary to ensure facilities are maintaining certain standards, it often relies on the companies to police themselves, which has led to fraudulent practices by some pharmaceutical companies. And in the area of new drug review, FDA employees fear rejecting a new drug could hurt their careers.

The simple fact is no drug is 100 percent safe, and it can take years to determine dangerous side effects of drugs. Until the FDA can be free from pharmaceutical industry influence, it is doubtful that dangerous drugs will be prevented from being sold. But lawsuits and the judicial system could help change this by holding pharmaceutical companies accountable for dangerous drugs.