Congress, GAO, Commissioner Emphasize Stricter Enforcement of Medical Device Regulations

After months of criticism of FDA’s approach to clearing medical devices for market, the House of Representatives’ Energy and Commerce Health Subcommittee held a hearing on June 18, 2009 to address FDA’s current premarket and postmarket processes for ensuring the safety and effectiveness of medical devices.  During the hearing and in the weeks that followed, Congress and the FDA’s new leadership have made it clear that enforcement of medical device regulation will be a “high priority” in the years to come.(1) 

At the hearing, Committee Chairman Rep. Frank Pallone (D-N.J.) called the current device approval process “broken”, saying that legislation is needed to ensure that certain review processes are not being abused.(2)  Other members of Congress and hearing witnesses noted that the problem may not be the law, but rather how the law has been enforced.(3)  Rep. John Dingell (D-Mich.) indicated that FDA may simply have “too much discretion” in determining the marketing pathway for medical devices.  Rep. Christopher Murphy (D-Conn.) added that the regulations are “only as good as the regulators and the agencies that are meant to enforce them.”(4) 

Marcia Crosse, director of the health care division at the Government Accountability Office (“GAO”), testified at the hearing and produced a testimonial GAO report identifying shortcomings in FDA’s premarket review, postmarket surveillance, and manufacturing establishment inspections.(5)  In her report, Crosse highlighted the findings of a January GAO report that concluded that FDA has not taken appropriate action to ensure that all high-risk devices are approved through the most stringent pathway.(6)  Crosse also discussed problems in the postmarket realm, noting that the agency’s assessment of device risks has been hindered by its inability to review all the of medical device adverse event reports that it receives.(7)  Crosse noted that the GAO has consistently drawn attention to deficiencies in FDA’s processes, but to no avail.(8)

In interviews the week of the hearing, FDA Commissioner Dr. Margaret Hamburg noted that enforcement will be a priority for the new agency leadership and that the Obama administration will be more aggressive in its enforcement efforts than its predecessors.(9) Hamburg has said she wants to take a “hard look” at the FDA premarket notification (“510(k)”) process and has staked out a position that the agency’s mission as a public health entity comes before approving new products for marketing.(10) 

As evidence that the agency may already be tightening the reins on industry, FDA’s new director of the Office of In Vitro Diagnostics, Alberto Gutierrez, said at a July 20 conference that companies producing diagnostic tests can expect more aggressive regulation.(11)  Gutierrez critiqued certain elements of the current 510(k) process as well as FDA’s use of enforcement discretion with respect to laboratory-developed tests.  Gutierrez says that Hamburg and the new FDA leadership is planning “huge changes” at the agency and diagnostic tests will be no exception.(12)