Drugged out on the Hill

The Framers of the U.S. Constitution purposefully divided governance among three separate but interdependent branches, intending to ensure the principal powers - legislative, executive and judicial - were not concentrated in a single branch. These are the “checks and balances” we all learned about in civics classes.

However, when it comes to congressional oversight of executive branch regulatory agencies, too often the system has been perverted by congressional politics, posturing and preposterousness.

It has become popular for members of Congress and others to lambaste the Food and Drug Administration. No longer do they complain about the indolent, overlong reviews and a paucity of approvals, as they did several decades ago. The pendulum has swung, and now they berate regulators for being insufficiently concerned with drug safety and too cozy with industry.

But these more recent criticisms do not stand up to scrutiny. A recent speech by Rep. Rosa DeLauro, Connecticut Democrat and chairwoman of the subcommittee that appropriates FDA funding and who considers herself an expert on the agency, illustrates that not only is the FDA broken but so is its congressional oversight.

Like many politicians, Mrs. DeLauro seems to exist in a parallel universe. For example, in the speech she:

* Refers repeatedly to the “undue influence”of industry over the FDA.Ah, that must be why approvals have decreased markedly during the same time period that R&D expenditures have tripled.

* Notes that “the IOM [Institute of Medicine] has proposed a moratorium to ban advertisements for a two-year period after a drug’s approval while initial questions of that drug’s safety are still being examined and considered.” This is unnecessary and unwise because studies show newer drugs are, on average, better at saving lives than older ones and that direct-to-consumer advertising induces patients to seek physicians’ help for their ailments earlier than otherwise.

So what does Mrs. DeLauro suggest? “I have proposed legislation along those lines to establish a moratorium, because we must ensure consumers know what they are getting, and drug-makers know what they are promising.”

This would make it even less likely that patients would receive important new drugs, or that drug companies could recoup their development costs on a drug before its patent runs out. (As it is, only 1 in 3 drugs recovers its development costs.)

* Cites “evidence” from the Union of Concerned Scientists (which is consistently and stridently anti-technology and anti-industry) about FDA senior managers’ inappropriate meddling with scientific decisionmaking: “A 2006 survey conducted by the Union of Concern [sic] Scientists showed that many FDA scientists from all Centers complained about interference from top level FDA appointees on behalf of corporate and political interests. They feel that factors other than good science play a role in important FDA decisions. And that may be why too many good scientists continue to leave the agency at a time when we should trying to attract them and support their work.”

But Mrs. DeLauro neglects to mention that the survey results were subject to a huge sampling error, making interpretation of the data impossible. Moreover, during my own lengthy tenure at the FDA, I found the scientists who register such complaints tend to be the very dregs of the work force - malcontents and chronic complainers who try to compensate for their inadequacies by raising spurious alarms.

* Relates concerns that user fees create a conflict of interest and enable industry to exert “undue influence” on the FDA. Those assertions are non-sequiturs: The fees are fixed and compulsory, whether regulators approve the drug or not, or perform their reviews expeditiously or slowly. In any case, money is fungible; and if Mrs. DeLauro doesn’t like user fees, she and her colleagues should eliminate them and appropriate funds. (That’s a sound idea for other reasons: User fees are only a discriminatory tax on one industrial sector and are particularly punitive to smaller, more innovative companies.)

In an op-ed article in March, Mrs. DeLauro claimed the FDA must begin “respecting independent science and pushing back against outside pressure.” The reality is that the most relentless and destructive outside pressure has come from members of Congress, particularly Mrs. DeLauro herself, Democratic Reps. John Dingell and Bart Stupak, both of Michigan, and Sen. Ted Kennedy of Massachusetts, all of whom seem to think the $58 billion spent annually on pharmaceutical research and development comes from the tooth fairy.

The inability of an influential, supposedly “expert” member of Congress to grasp the nuances of drug development and its regulation contributes to my pessimism about FDA’s near-term performance. Agency officials will try to avoid ruffling congressional feathers. That means no aggressive approvals or any other decision that will open the FDA to charges of too close a relationship with industry or too permissive a view of drugs’ risk and benefit. And certainly there will be no disciplining of rogue employees with an ax to grind who now freely and publicly criticize drugs and decisions with which they disagree (in clear violation of FDA’s ethics rules).

The bottom line: At a time when the U.S. population is aging and needs innovative new medicines for a wide spectrum of degenerative and infectious diseases, the nation’s drug regulator is increasingly inefficient, slow, poorly managed and risk-averse. Congressional oversight is misguided and inadequate. Americans will go on dying for genuine FDA reform.