- The Washington Times - Thursday, March 27, 2008

ANALYSIS/OPINION:

The head of the Food and Drug Administration, the nation’s most ubiquitous regulatory agency — which regulates products accounting for 25 cents of every consumer dollar — is crying poor. Dissatisfied with the 5.7 percent increase proposed in the Bush administration’s 2009 budget, FDA Commissioner Andrew von Eschenbach said in a Wall Street Journal interview that the agency is in a financial bind and that he had requested more.

But mismanagement and adherence to flawed policies and programs are some of the FDA’s most severe problems, and merely throwing more resources at the agency is likely only to give us more of the same. If Dr. von Eschenbach were willing to trim, revise or eliminate programs that are ill-conceived and counterproductive, he would both free resources for essential functions and improve the efficiency and effectiveness of FDA regulation. He could do more with less.

But that is not Dr. von Eschenbach’s style. He is known within the agency as something of a Pollyanna who will not make the tough decisions. “There’s a frustration that he talks in platitudes, generalities, nonspecifics, as opposed to laying out specific answers and budgetary proposals,” says Bill Hubbard, who retired in 2005 as an FDA associate commissioner.

Here are a few specific suggestions:

• The Drug Watch program has more to do with public relations than public health. According to the FDA, it makes “emerging safety information” publicly available before the agency has “fully determined its significance.” Drug Watch is “not intended to be a list of drugs that are particularly risky or dangerous for use; listing of a drug on Drug Watch should not be construed as a statement by FDA that the drug is dangerous or that it is inappropriate for use.” Then-FDA Deputy Commissioner Scott Gottlieb characterized the data that would appear on Drug Watch as “still un-scrubbed by scientific rigor.” That is to say, worthless — except perhaps for plaintiffs’ attorneys trolling for business.

• Last year, the FDA announced a plan to perform a comprehensive assessment of the safety of some new drugs within 18 months after their introduction, and to issue a sort of report card on their performance. Although this may sound plausible, it is inconsistent with data showing that, in fact, newer drugs confer an advantage over older ones in reducing mortality.

• The FDA plans to require that every new genetic construction in an animal that employs gene-splicing technology be evaluated under the same procedures and regulations as those for drugs used to treat animal diseases. In other words, the genetically altered animal would be treated as though it were a new drug. A far more apposite model for gene-spliced animals would be FDA’s oversight of traditional foods and food additives; of “natural mutants”; and of livestock clones, or identical twins, which FDA has decided are safe to eat. This would ensure food safety but would be far less labor- and time-intensive for FDA personnel.

• Many FDA evaluations take far longer than they should. These include approvals of new drugs, vaccines, medical devices (such as artificial joints) and food additives, as well as affirmations that new food ingredients are “Generally Recognized as Safe.” There is minimal accountability for dilatory performance. Greater accountability, more expeditious decisionmaking, and improved risk-benefit balancing would expend existing and additional resources more efficiently.

• Most day-to-day evaluations and approvals of drugs, medical devices and food products are performed quite autonomously within the FDA’s various decentralized units, and yet there are massive, largely superfluous bureaucracies that serve the commissioner and a horde of deputy commissioners, associate commissioners and assistant commissioners. These should be trimmed drastically, freeing vast resources for the agency’s essential programs.

• Better management and greater discipline would result in higher morale and productivity. Dr. von Eschenbach has permitted self-styled whistleblowers to flout the FDA’s ethics rules by publicly contradicting agency policy and disparaging drugs and drug companies that they dislike.

The FDA may lack needed resources for inspections and safety monitoring of approved drugs, but there is also poverty of sound management and insight. Dr. von Eschenbach, who is a surgeon, should take out his scalpel and start cutting.

Henry Miller is a physician and fellow at Stanford University’s Hoover Institution. He was an official at the Food and Drug Administration from 1979 to 1994.

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