Senators butt heads over proposed device (and drug) industry regulatory overhaul

Alas, the momentum has been lost in the Senate, where the two parties are squabbling over their competing priorities, and chances of passage by the end of President Barack Obama’s term are declining.  The Wall Street Journal reports that Senate Democrats are putting forth their own version of the bill that would increase funding for the National Institutes of Health and FDA by $5 billion per year, but does not include the regulatory overhauls in the House bill.  They are also seeking to limit drug price increases.

Meanwhile, the article says that the Republican bill would create an NIH Innovation Fund to pay for President Obama’s priorities like his Precision Medicine genetics and Big Data initiative and “moonshot” cancer research.  “Our goal is to move treatments and devices more rapidly into the medicine cabinet,” Sen. Lamar Alexander (R-TN), told The Wall Street Journal. In other words, the Republicans are more focused on the regulatory overhauls that Democrats in the Senate are less keen on.

Patient safety advocates are wary of them as well. And former FDA commissioner Dr. Margaret Hamburg weighed in during her farewell address last year, saying, “There’s a misperception that you might be able to speed up innovation by lowering the standards for safety and efficacy, and I think that would be a terrible mistake that would not only just damage patients, but industry as well.”

Specific regulations mentioned by The Wall Street Journal include regulations that would enable more drug/device combination products (such as drug-eluting stents) to be regulated through the less rigorous device pathway, and provisions to decrease FDA’s regulation of laboratory-developed tests, as well as the accuracy of medical software.  The House’s 21st Century Cures Act requires the FDA to issue final guidance documents on the role of each Agency center (such as its drugs, devices and biologics arms) in reviewing combination products, but industry (and its legal representatives) want Congress to pass a statutory change to the laws governing which approval pathway (drug or device) should be the primary one for products with both physical and chemical means of action.

FDA’s regulation of lab-developed tests is also a long-running area of contention. The industry last year released long-awaited plans to regulate the LDT arena.  Implementation was scheduled to occur last year, but has not yet commenced, perhaps due to vocal opposition from the American Clinical Laboratory Association.  AdvaMed supports the LDT regulations because it represents companies that make the diagnostic equipment for use at third-party sites (not centralized laboratories), and are already regulated closely by FDA under its device pathway.  The trade association recently commended the Senate for its efforts on the emerging legislation.

Shortly before passage of the 21st Century Cures bill in the House, industry insiders at a rooftop gathering in DC hopefully noted to FierceMedicalDevices that the legislation was not being debated on the partisan airways of Fox News or MSNBC.  However, it appears that a legitimate disagreement between Senate Democrats and Republicans over the balance between patient safety and innovation is enough to stall the bill in the upper chamber’s Health, Education, Labor and Pensions Committee.

REFERENCE:  Fierce Medical Devices; 07 MAR 2016; Varun Saxena

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