During my tenure at the FDA I was the senior official in charge of advisory committee oversight and the final decision-maker on who got a COI waiver and who did not. Many did not — but those who did received their waivers because FDA professional career staff made a strong case that these people weren’t just important to the advisory committee — but critical.
And we should all pay attention to the nomenclature. It’s not about “conflict of interest” – it’s about (as Secretary Sebelius correctly says) “interest.” And having an “interest” is not necessarily a bad thing – as long as you’re transparent about it.If we allow FDA adcomms to become the realm of the second best and the almost brightest –what have we done to the advancement of America’s health? The answer is a significant disservice.
In the February 7, 2010 edition of The Lancet, Richard Horton points out that the battle lines being drawn and between clinician, medical research and the pharmaceutical industry are artificial at best -- and dangerous at worst. Dangerous, because all three constituencies are working towards the same goal -- improved patient outcomes.
Horton’s main point is that we must dismantle the battlements and embrace of philosophy of "symbiosis not schism." It's what's in the best interest of the patient.
And so it is with this in mind that I share some promising news (as reported today in The Hill.)
GOP wants FDA bill to boost drug industry's role
Republicans want to roll back new conflict-of-interest rules they say are depriving the Food and Drug Administration of needed expertise from the drug industry.
Democrats, meanwhile, will focus largely on the safety of imported drugs as Congress begins work on a five-year FDA reauthorization bill.
Congress tightened the FDA's conflict-of-interest rules in 2007, as part of the last FDA reauthorization. But Republicans on the House Energy and Commerce Committee said they may try to loosen the standards in the next reauthorization, which needs to pass next year.
Committee Chairman Fred Upton (R-Mich.) said the upcoming bill should reverse "rigid, unrealistic conflict-of-interest provisions" that have delayed drug approvals. The rules govern who can participate in FDA advisory panels, which study safety and effectiveness issues.
"No longer can we afford to sideline experts simply because of their ties to the pharmaceutical industry," Rep. Phil Gingrey (R-Ga.) said Thursday at an Energy and Commerce health subcommittee hearing.
Janet Woodcock, the director of FDA's drug center, said the limits have slowed down the advisory committee process. The agency sometimes goes through the long haul of finding experts in a given field only to discover ties to the pharmaceutical industry toward the end of the process, she said.
The FDA has already begun negotiating with drugmakers and consumer advocates over the reauthorization bill. Thursday's hearing marked the first formal involvement from Congress.
Technically, the purpose of the FDA bill is to reauthorize the programs through which drug and medical device companies pay the FDA to review their products for approval. But because it's a must-pass measure — the people and offices that approve new products are paid for almost entirely by industry fees — it consistently becomes a magnet for broader policy changes.
Upton said Thursday that he also wants to reexamine a piece of the last reauthorization that gave the FDA more power to regulate drugs after they've been approved. The FDA can now require drugmakers to study certain safety issues and add new warnings to drug labels.
Upton and other committee Republicans say FDA overregulation is stifling innovation and preventing drug and device companies from creating new jobs. Rep. Henry Waxman (D-Calif.) argued that while getting new products to market is important, the FDA's mission should be protecting public health rather than fostering job creation.
Energy and Commerce Democrats indicated that the safety of imported drugs will be their biggest policy focus. Rep. John Dingell (D-Mich.) began working on an import safety bill in 2007, the food-safety portion of which passed on its own in 2009.
The FDA inspects foreign factories far less often than domestic ones, and it can't make a surprise visit outside of the United States. Those limitations received extra scrutiny following the 2007 heparin contamination, which Dingell cited repeatedly at Thursday's hearing.
