Regulatory Smackdown

On Wednesday, July 27th, 2011, the New York Times reported that allies of the medical device industry were waging an extraordinary campaign to discredit an upcoming report by one of the country's pre-eminent scientific groups that is examining possible new regulations on the industry.  As of this posting, the report was released on Friday by the Institute of Medicine (IOM). The report's recommendation is to "scrap" the current system, which elicited reactions from outright rejection by industry officials, to acceptance by patients groups and disbelief from federal regulators, who had commissioned the report.  The report was commissioned by everyone's best friend the Food and Drug Administration on the heels of recent recalls pertaining to metal-on-metal hips, pumps and defibrillators.

The Institute of Medicine is part of the National Academy of Sciences, a widely respected organization. The report goes on to say that it is not immediately clear as to what impact, if any, this report will have, or if it would be adopted.  Industry dissenters included Medtronic, Boston Scientific and Johnson & Johnson.  The mouthpiece for the industry, AdvaMed, immediately weighed in issuing a statement from Stephen J. Ubl, that "this would be a disservice to patients and the public health."  Patient groups and some doctors applauded the panels findings, urging to create a system that examined a device's benefits and harms before patients were exposed to it. On the other hand, FDA officials were caught off guard.

The study in question reviewed the 501(k) clearance process under which moderate risk products are approved by the FDA.  The study DID NOT examine devices that carry the highest risk to patients if they fail.  The study concluded that the 510(k) process lacks the legal basis to be a reliable pre-market screen of the safety and effectiveness of moderate risk devices.  The FDA's immediate response was that it believes that the 501(k) process should not be eliminated but is open to new proposals and approaches in its responsibility as the gatekeeper for device reviews.

As an unknown observer mentioned, "the first commandment of medicine is to protect the consumer from harm."  But what does this say about our value system?  The companies that immediately reacted to this study, have themselves been culpable of numerous recalls.   The Washington Legal Foundation, whose tag line is "Advocate for Freedom and Justice," had fired a preemptive salvo on June 28th, 2011  urging the FDA not to use any advice or recommendations provided by the IOM, claiming violation of the Federal Advisory Committee Act.  The brief was filed with pro bono assistance from Robert Klepinski, an attorney from Minneapolis, Minnesota. Mr. Klepinski is an attorney who counsels pharmaceutical, medical device and biotech companies on FDA policy, in addition to once working for Medtronic as a regulatory attorney.

With the recent controversy swirling around metal-on-metal hips like the DePuy ASR and ASR XL, and the Zimmer Durom Cup, could these scenarios be another example of profits taking precedence over science and technology?  Interestingly, some other industry websites even have links to law firms that are looking for patients interested in participating in class action lawsuits against some of these companies.  So the complex question must be asked of our readers, how does the industry find a balance between corporate sponsorship and science?  Regardless, the fact remains that without clinicians working with companies, and private investment, innovation and technological improvements cease.  And what happens to the patient if government regulations are bought and paid for by corporate interests?

The medical device court of public opinion is waning. The behavior of the insurance industry, a shell game at its best, and the recent public slaughtering of the device industry in the national press has made it evident that the integrity of the U.S.healthcare and medical device industry is under siege.  Whether our bloggers agree to disagree, the fact remains that those companies that are publicly traded have become slaves to their master, the Street.  What does it say about the medical community when there is such a dichotomy in principles?  Whom does one believe?  The unfortunate aspect of this debate is that there are companies that abide by the rules, and companies that know that the risks are outweighed by the potential profits.  It all comes down to a cost-benefit analysis.  Could it be cheaper to incur the fine or settle a legal claim than it is to properly evaluate the safety and efficacy of a new technology?  Let's be honest, we're all in this to make money, but we're also in this to make the best products that money can buy without compromising the patient's safety.  The current system is not sustainable.  As companies cry out for additional self-regulation, have we learned anything from the most recent crisis in the financial community?  The key to our survival is finding balance and reason in the regulatory oversight process, until then, thrive to survive.