While some folks in Washington are picking out their finest for the Inaugural Ball next week, officials at the FDA are putting on their PR flak jackets and wielding their rule-making pens.
There’s no shortage in the supply of FDA news in the final days of the Bush administration, which presided over what many view as a disastrous chapter in the history of the agency: a record number of post–market safety problems, including Vioxx, Avandia, and Paxil, the heparin crisis, chronic underfunding, declining approvals, an under-inspected supply chain, internal strife and suppression of science, and revelations that clinical trials for approved drugs have been massaged, ghostwritten, and conflated, or just plain withheld to promote sales.
As a TV drama, this final flurry of bad news and fast moves obeys all the rules of a good season finale. As a public health agency, it just spells trouble.
Episode 1: On Monday, a report by the Inspector General of Health and Human Services found that the FDA does little if anything to monitor conflicts of interest among clinical trial investigators. The agency requires drug and device companies to submit with its clinical trials forms disclosing any conflicts of interest that investigators running those trials may have. But according to the New York Times, “the agency did not receive forms disclosing doctors’ financial conflicts and did nothing about the problem” in 42 percent of clinical trials, and of those forms submitted, FDA officials didn’t look at them a third of the time.
In a year when conflict of interest investigations in medicine have turned up millions of undisclosed dollars in industry pay and evidence has surfaced that clinical trials have been designed, manipulated, or halted at the behest of pharmaceutical marketing departments, it seems nothing short of careless for the agency not even to be looking. Or, as the New York Times editorial board put it, “lame.”
Episode 2: Despite vocal concern from consumer advocates (us included), the FDA finalized an earlier guidance and enacted eleventh-hour rules that will allow pharmaceutical reps to distribute journal articles on off-label indications, though marketing and promoting for unapproved uses is illegal. In the guidance, the FDA says it doesn’t have the authority to require the companies to do clinical trials on such off-label indications, and that companies are no longer required to submit such articles to the FDA for approval.
By not requiring either of these, Peter Lurie of the Public Citizen Health Research Group told the BNA that FDA has removed any incentives for companies to test and prove the indications through well-designed trials.
“Right now, there's a bright line that distinguishes the on-label from the off-label use,” Lurie said. “But that line is erased by this, and it will create confusion in the minds of the doctors, and ultimately they will begin to equate the evidence that supports the on-label from the off-label, and that is not justified.”
Physicians who see drug reps: be prepared to be flooded with reprints from journals you’ve never heard of.
Episode 3: Last week, nine top level FDA scientists wrote to HHS Secretary-appointee Tom Daschle, confirming the systemic mismanagement and acrimony we’ve been hearing about for awhile now. The authors have no shortage of examples on how their work was derailed by agency politics, but this line stood out: “Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the letter said.
This Financial Times editorial calls on the incoming administration to make fixing and funding the FDA a priority, and offers its European counterpart as a case study. “The European Medicines Agency has moved more swiftly than the FDA in approving some new medicines, establishing principles for generic biological drugs and fostering partnerships with commercial and academic researchers to rethink regulation,” the Times wrote.
Season Cliffhanger: On Monday, the HHS transition team named Dr. Frank Torti, an oncologist who joined the FDA last April as chief scientist, to be acting director until a permanent commissioner is found. Speculation on who that might be continues, though you may remember some FDA watchers on the Hill had asked the incoming Obama administration not to name an acting or permanent commissioner from within the current agency.
How else could we end this post? Stay tuned...