Med device bill won’t weaken FDA

The recent Congress Blog post “Medical devices: The risks of cutting corners” (May 5), mischaracterized the bipartisan legislation recently passed out of the Senate health committee and overwhelmingly approved by the full House that would improve the efficiency, predictability and transparency of the Food and Drug Administration’s (FDA) review process for breakthrough medical technologies.

Contrary to writer Sanket S. Dhruva’s claims, the Advancing Breakthrough Devices for Patients Act of 2016 does nothing to lessen the FDA’s current rigorous approval standards for breakthrough medical devices and diagnostics but instead will improve access to potentially life-saving and life-enhancing treatment options for patients who may have no alternatives. 

{mosads}The legislation builds on existing law, which allows for FDA priority review of medical technologies used in the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions and meet one of four criteria: it is a breakthrough technology; there is no approved alternative; it offers a significant advantage over existing alternatives; or its availability must be in the best interest of patients. The legislation clarifies these existing criteria, which have been in FDA statute since 1997, and codifies the process for priority review. 

It is important to note that the FDA alone would determine which products meet the criteria to qualify as “breakthrough,” so it in no way “dilutes” the term as the writer claims. Furthermore, the legislation complements the FDA’s Expedited Access for Pre Market Approval guidance by establishing this priority review process for breakthrough technologies in statute. 

The writer also makes several unwarranted assumptions about the types of clinical trials allowed in support of breakthrough technologies. Ensuring clinical trials are “efficient” is in line with long-standing policy that the FDA determine the most effective methods for gathering data to provide a reasonable assurance of a medical technology’s safety and effectiveness. The size and scope of a clinical trial should be determined by the data requirements needed by the FDA to make this decision, not some arbitrary number. 

Priority review of breakthrough products at the FDA is important for providing patient access to critical therapies, which is why the legislation has received strong bipartisan support in both the House and Senate, from numerous patient groups, and from the FDA as well.

From Janet Trunzo, senior executive vice president, Technology and Regulatory Affairs, Advanced Medical Technology Association, Washington, D.C.


States can fight back against feds

The recent conflict between North Carolina and the U.S. government over “bathroom laws” is just another example of our government gone wild (“DOJ files lawsuit against North Carolina over bathroom law,” May 9). The U.S. Constitution says that the federal government is supposed to be in charge of the military, immigration laws, foreign policy, the Treasury, etc. I’m not sure where the Constitution gives them the right to dictate to states their bathroom laws. Maybe a warped interpretation of the Civil Rights Act does; maybe it’s just political correctness gone berserk.

Either way, what’s needed is a way for the states to have the power to clarify what is, and what is not, in the scope of the federal government’s power. That’s where an Article V convention can be utilized. Article V of the U.S. Constitution gives state legislatures the power to call a convention for purpose of proposing amendments to the Constitution. If 38 states ratify the proposed amendments, they become part of the U.S. Constitution. The 50 states do have an “escape hatch” in instances like these, where the feds have clearly overstepped their authority.

From Paul Carrozzo, Algonquin, Ill.

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