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Drug Makers Decry FDA Safety Push

Jul 1, 2008 | Parker Waichman LLP

Drug makers are complaining that the Food & Drug Administration (FDA) is too focused on, of all things, safety.  The pharmaceutical industry says the FDA' s tougher stance is slowing the arrival of new drugs to the market, but consumer advocates - citing recent scandals involving defective drugs - say a stronger focus on safety is long overdue.

According to the Wall Street Journal,  the FDA approved just 19 new medicines last year, the fewest in 24 years, and announced about 75 new or revised "black-box" warnings about potential side effects -- the agency's strongest -- twice the number in 2004. The number of so-called approvable letters, which typically postpone FDA approval decisions pending more data, increased by 40% last year.

Drug makers are less-than-enthusiastic about the FDA's new approach. Schering-Plough Corp. Chief Executive Fred Hassan told The Wall Street Journal that the new safety focus means that drug companies must now spend significantly more time and money to get a drug approved - and even then, approval is not guaranteed. "What will it take to get new drugs approved?" Hassan said. "The point is, we don't know."

The FDA's new caution can be traced to the Vioxx debacle. Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The FDA ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

Shortly after Vioxx was pulled from the market, it was revealed the FDA had tried to silence the drug expert who headed that analysis. Dr. David Graham, associate director for science in the FDA Drug Center’s Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.

Following the Vioxx mess, several other drug safety scandals intensified pressure on the agency.  For instance, after a study was published last May detailing heart risks with the diabetes drug Avandia, it was revealed that in 2005 GlaxoSmithKline had informed the FDA of a study it had conducted that produced similar results. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues.  

And just this year, it was learned that the makers of Vytorin withheld a study  that found the expensive cholesterol medication was no more effective than cheaper statins for two years.   Poor FDA oversight of foreign drug plants allowed tainted heparin to kill at least 149 people this year, and the agency has been slow to take strong action against the stop-smoking drug Chantix, which has been linked to suicides.

These and other scandals have strained the credibility of both the FDA and the pharmaceutical industry.    The FDA has apparently heard the criticism.  In addition to being tougher on new drug approvals, the agency is adding warnings about cancer risk to arthritis drugs for children, and warnings about suicide risk to epilepsy drugs.  The FDA is also considering instituting tougher approval criteria for diabetes drugs.

None of this sets well with the pharmaceutical industry, which relies on new drug approvals to stay in the black.  But considering the industry's recent history of manipulating clinical data, concealing dangerous side effects and aggressively promoting risky products, drug makers have only themselves to blame.


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