A Sign of the Times – FDA’s Medical Device Top Brass Under Fire From Within and From Capitol Hill

By James R. Phelps & Kurt R. Karst –      

On November 17, 2008, Representatives John Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations of the U.S. House of Representatives, announced their most recent investigation of FDA – “whether managers within the [FDA] Center for Devices and Radiological Health (CDRH) knowingly corrupted the scientific review process and approved or cleared medical device applications in gross violation of laws and regulations designed to assure the safety and effectiveness of medical devices.”  The investigation was prompted by an October 14, 2008 letter written on behalf of a group of CDRH scientists and physicians who allege that CDRH managers have “corrupted the scientific review of medical devices.” 

The October 14, 2008 letter to Chairman Dingell is quite remarkable and includes several serious allegations.  According to the letter:

This misconduct reaches the highest levels of CDRH management including the Center Director and the Director of the Office of Device Evaluation (ODE) . . . .  To avoid accountability, these managers at CDRH have ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law. Furthermore, these managers have also ordered, intimidated and coerced FDA experts to make safety and effectiveness determinations that are not in accordance with scientific regulatory requirements, to use unsound evaluation methods, and accept clinical and technical data that is not scientifically valid nor obtained in accordance with legal requirements, such as obtaining proper informed consent from human subjects.  These same managers have knowingly avoided and failed to properly document the basis of their decisions in official Agency records.

Under the banner of regulatory “precedent,” managers at CDRH have demanded that physicians and scientists review regulatory submissions employing methods, and accepting evidence and conclusions, that are not scientifically proven and clinically validated. These demands appear to be based on the misguided notion that because flawed methods, evidence and conclusions were used or accepted in the recent or even the remote past, we must continue to blindly and knowingly accept these flawed methods, evidence and conclusions and continue to use them as the basis for regulatory recommendations. Such invalid regulatory “precedent” goes against current scientific and clinical evidence. Rather than remedy past regulatory or scientific errors after they come to light, and rather than applying the best and latest scientific knowledge and methodology, these managers at CDRH knowingly continue to make the same regulatory and scientific mistakes over and over again. Rather than recall, re-evaluate or otherwise deal with potentially unsafe or ineffective devices that are already on the market, these managers at CDRH continue to approve more devices of the same kind in a non-transparent and non-scientific manner. This is especially true of the 510(k) program but also applies to the PMA program as well as the advice and guidance given to manufacturers before they make regulatory submissions. The practices described above represent an unwarranted risk to public health and a silent danger that may only be recognized after many years.

The October 14, 2008 letter reportedly follows up on a similar letter sent by some CDRH scientists to FDA’s Assistant Commissioner for Integrity and Accountability on May 31, 2008.  In a November 17, 2008 letter from Reps. Dingell and Stupak to FDA Commissioner von Eschenbach, the Representatives: (1) express concern that “no action has been taken to address the serious concerns raised by CDRH scientists or the retaliatory behavior of CDRH managers toward those concerned FDA employees;” (2)  remind FDA officials that it is a violation of Federal law to retaliate against whistleblowers and to interfere with a congressional inquiry; and (3) request a briefing by FDA no later than December 1, 2008 of what actions have been or will be taken to respond to the allegations raised in the October 14, 2008 letter. 

Managing FDA is an excruciatingly difficult task.  One of the principal reasons this is so is laid bare in the letters discussed above.  At this stage, it is impossible to know what will happen to the CDRH personnel involved.  Do the complainants have a better grasp of good scientific methodologies than the senior people at CDRH?  Will they be viewed as heroic whistleblowers or back-stabbing knaves?  We may never learn.

We can, however, foresee yet another season of congressional activity – grillings by Hill staff and maybe hearings.  The one easily predictable consequence of all this is that FDA, and especially CDRH, will for some time to come be in a defensive mode.  When this happens, history teaches that FDA reviews will reach a new level of difficulty.  The affected personnel will be distracted to attend to the allegations.  The managers will have a heightened interest in making judgments that no one – not even the worst informed employee – can criticize. 

Will the enhanced rigidity of the approval system that occurs as Congress sorts out FDA’s personnel issues give the public access to new technologies in an appropriate time frame?  Time will tell.