Time for a basic change in FDA approval process?

Events of the past week lead me to think it may be time for a basic overhaul of the FDA process for approval of drugs and medical devices and a uniform national system for pharmaceutical and medical device liability.

 Recently we have seen an unsuccessful proposal to give civil immunity in Georgia for manufacturers of FDA-approved medical devices and pharmaceuticals that employ at least 200 people in manufacturing or R&D in Georgia.  Even Georgia’s conservative legislators decided immunity was a bad idea.

 And earlier this week the U. S. Supreme Court decided, in Wyeth v. Levine, that FDA approval does not preempt products liability claims under state laws.

 Now there’s an interesting article by Alicia Mundy in today’s Wall Street Journal about political lobbying overcoming scientific objections to approval of a medical device at the Food and Drug Administration.

 The article focuses on the fast-track FDA approval of Menaflex, an implant for repair of torn meniscus in knees. Made of cow collagen, it is intended to stimulate regrowth of tissue that acts as a shock absorber within the knee. The current standard treatment is to sew up the torn meniscus tissue.

 The manufacturer of Menaflex apparently started out applying for FDA approval on the standard track that requires clinical trials, but grew frustrated with an agonizingly slow process. Then, the critics say, it started political lobbying for fast-track approval, bypassing the scientific review process.

 Having dealt with slow, unresponsive government bureaucracies many times, I can understand their frustrations. And having seen too many efforts by companies to immunize themselves from accountability, I understand the medical review scientists’ concerns about elevating politics and profits over scientific integrity.

 The WSJ article points out that Menaflex has been used in Europe for years. European regulators generally require only that medical devices perform as stated and don’t apply a risk-benefit evaluation akin to the FDA’s full approval process.

 My perspective on this is a little different from many of my trial lawyer colleagues. I have a child with neurofibromatosis (NF), a genetic disorder that made her deaf and for which there is currently no treatment approved by the FDA. She and I have both run marathons as fundraisers for NF research.

 The NF market is too small a market to make it a profitable priority for drug companies, who can make bundles on drugs and devices for common but less devastating ailments. The process of gaining FDA approval for a promising new drug  for NF would be prohibitively slow and expensive. We can’t compete with the profitability of Viagra or Menaflex. So when I spoke to an international medical researchers conference last June, I encouraged them to look for bridge therapies (e.g., nutritional supplements, off-label uses of already approved drugs, etc.) that could, without the need for FDA approval, provide help for the current generation of kids with  NF.

 As the majority of the Supreme Court recognized in the Wyeth case, and as Georgia legislators recognized in stalling the FDA immunity bill, the FDA approval process has problems. Between a medical review process that is sometimes too slow and expensive, and end-runs that put profits ahead of science, confidence is lost.

 Perhaps it is time for Congress to change the process in order to both encourage innovation and rapid delivery of improved products and preserve accountability. 

 They could adopt a more streamlined approval process, somewhat akin to that in Europe, that requires only that drugs and devices perform as stated, without exhaustive risk-benefit analysis.

 But the tradeoff would be preservation of the secondary regulation role played by tort laws, which the majority of the Supreme Court recognized in Wyeth.

 f unbridled tort liability under the laws of 50 states is too much of a deterrent to innovation, as the industry claims, then devise a new set of uniform federal rules governing liability of pharmaceutical and medical device manufacturers. The tradeoff there could be a less onerous and less expensive process, defined by federal law, to obtain fair compensation, perhaps in exchange for capping punitive damages in pharmaceutical and medical device cases.

This suggestion would likely draw fire from both sides — the manufacturers who want immunity and my trial lawyer brethren who want no restrictions of civil liability.  However, something along these lines may be needed to serve the public interest in both economic viability of medical progress and fair compensation for those who suffer the consequences when the train runs off the tracks.