FDA Update

Investigation Reveals Bonuses at FDA Go to Top Officials, Not Inspectors

An investigation into the Food and Drug Administration payment system has revealed that large cash bonuses have gone to the agency’s top officials and not to staff inspectors who are charged with ensuring the safety of the nation’s food and drug supply.  The findings were detailed in a report from an ongoing investigation by the House Energy and Commerce Committee.  The report, which comes on the heels of several high-profile failures, caused the chairman of the committee to severely criticize FDA and their “retention bonus” system.  “These back-scratching bonuses could be used to hire inspectors that might have gone to China and uncovered the unsafe manufacturing practices that led to the heparin deaths, or the tomato packers that shipped salmonella to hundreds of Americans,” said Chairman Rep. John Dingell (D-MI) in the committee’s June 26 release.  As an example, the report detailed that FDA’s chief of regulatory affairs received a $48,663 cash bonus while the highest field inspector bonus was just $2,500.

The investigation found that because of these bonuses, which are intended to keep key employees in place, some FDA managers and employees earn in excess of $200,000 a year which is a higher salary than cabinet secretaries or Members of Congress, according to the release.  In response, a FDA spokeswoman told Congressional Quarterly that the agency “employs a very knowledgeable, experienced and highly educated staff and has to compete with the private sector to attract individuals of the highest caliber” and that the information contained in the report is preliminary and more data will be coming to show how the system operates.

Drug Approvals Slowed Due to FDA Safety Focus, Claims Manufacturers

Progress on approving new drugs which would benefit Americans has been slowed to a crawl by the Food and Drug Administration’s increasing focus on drug safety and growing concerns about side effects.  A group of drugmakers and industry leaders told the Wall Street Journal on June 30 that the effect of FDA’s actions has resulted in new drugs being cancelled due to concerns that they would never be able to navigate the long regulatory path toward approval.  Consumer groups and watchdogs applaud the increased focus on safety citing the problems with drugs like Vioxx and others which were approved for use and arguing that warnings give patients and doctors more information about potentially serious side effects.

The story noted that in 2007 the FDA approved just 19 new medicines which was the fewest number in 24 years, and also announced about 75 new or revised "black-box" warnings which was twice the number issued in 2004.  In response to these facts and the perceived hurdles to approval, Schering-Plough has cancelled two drugs in development and Novartis has ended efforts to get two drugs approved for use in America despite their approval in other countries.  The US-Europe drug approval discrepancy also looms large in the debate.  Drugmakers say the FDA has become too cautious while Europe has moved ahead.  A top FDA drug safety official told the Journal that this discrepancy has been in existence for a long time because “different countries looking at the same facts and data arrive at different conclusions” and that drug approval petitions sent to FDA dropped by 33% in 2006 which helps explain the low number of approvals in 2007. 

FDA Deadline Approval Problems Study Flawed Admits Author

The author of a controversial study on problems with drugs that are approved quickly to meet Food and Drug Administration’s mandated deadlines has admitted that flaws existed in his analysis of the data.  According to a report in the July 3 Wall Street Journal, study author Daniel Carpenter, a professor of government at Harvard University, has also fixed the findings of the study but also stood by his conclusion that the push to meet deadlines was placing drugs on the market which have been more likely to develop severe safety problems down the line.  This correction and comments from FDA researchers were printed in the July 3 edition of the New England Journal of Medicine where the original study appeared. 

As reported in the April Newsletter, the study initially concluded that drugs approved just prior to the FDA deadline from 1993 and 2005, the 88 drugs approved near the FDA's deadline had a 14% chance of being flagged for severe safety problems such as adding a "black-box" warning to the drug's label, or a complete withdrawal from the market.  For 226 other drugs, that rate was just 3%.  However, according to the revised analysis, the severe safety problem rate is 15% for drugs approved soon before a regulatory deadline, and 5% for other drugs.  While this change does not seem drastic, the FDA’s economist told the Journal that its own figures showed a “modest increase” in the rate of safety problems with these deadline approved drugs and that the study’s findings would not hold up.  Dr. Carpenter admitted that his research missed some warnings but the FDA’s figures had also omitted some warnings.

President Signs Genetic Non-Discrimination Bill into Law

President Bush signed a bill on May 21 that prohibits discrimination against anyone whose genetic information shows a predisposition to illnesses such as cancer or heart disease.  The bill - HR 493 - the Genetic Information Nondiscrimination Act – prohibits health insurers from rejecting coverage or raising premiums for healthy people based on personal or familial genetic predisposition to develop a particular disease such as cancer, diabetes, and heart ailments.  The bill “protects our citizens from having genetic information misused, and this bill does so without undermining the basic premise of the insurance industry,” the President said in a press release.

At the Oval Office signing ceremony, President Bush praised the efforts of Sen. Edward Kennedy (D-MA), who was instrumental in pushing the legislation through Congress.  Bush said he wanted to pay homage to Kennedy, who was hospitalized due to his recently diagnosed brain tumor, as someone "who has worked for over a decade to get this piece of legislation to a president's desk.”  A number of other Members of Congress joined the President at the signing ceremony including the bill’s sponsor, Rep. Louise Slaughter (D-NY), a microbiologist who first sponsored this legislation 13 years ago.