Drug Shortage Oversight Remains Key GAO Concern As FDA Is Again Deemed “High-Risk”

Report again calls for improvement in oversight of medical device recalls by FDA, as well as for increased inspections of foreign establishments that make medical products for the U.S. market.

FDA remains on the list of “high-risk” areas in the Government Accountability Office’s (GAO) report on potential federal operation problems, but provisions of last year’s user fee reauthorization law could help eliminate GAO’s primary area of concern related to the agency’s handling of Rx products: drug shortages.

Improvements ratified under Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) include a direction that FDA take a more risk-based approach to its review of ex-U.S. medical product manufacturers, a requirement that FDA implement GAO’s 2011 suggestions for improving medical device recall procedures and a mandate that drug makers advise FDA of potential drug shortages.

Published every two years since 1990, the high-risk report lists “protecting public health through enhanced oversight of medical products” among nine items from the 2011 report in which congressional actions and executive branch initiatives have led to improvement, but not enough progress to be removed from the report entirely (Also see "When "High Risk" Is Safe: FDA Stays on GAO List For 2011" - Pink Sheet, 1 Apr, 2011.).

Two areas – management of interagency contracting and modernization of business systems at the Internal Revenue Service – saw enough improvement in the past two years to merit removal from high-risk designation, the report reveals, while two new concerns were added: limiting federal government financial exposure by better managing climate-change risks and mitigating gaps in weather satellite data.

Saying that “the importance of FDA’s role in ensuring our citizens’ well-being cannot be overstated,” GAO indicated that enhanced oversight of medical products, added to the high-risk areas in 2009, is an area of progress but one in which considerable challenges remain (Also see "FDA Oversight Of Medical Products Remains A "High-Risk" Concern For GAO" - Pink Sheet, 11 Apr, 2011.).

“Rapid changes in science and technology, globalization, unpredictable health crises, an increasing workload, and the continuing need to monitor the safety of thousands of marketed medical products have strained the agency’s resources,” the report states.

Specifically, GAO said its review identified problematic issues that have emerged more recently. These include drug availability, medical device recalls, implementation of the Safe Medical Devices Act of 1990, globalization, timeliness of medical product application reviews (including NDA and BLA reviews by CDER and CBER), and tracking medical product applications for children.

Drug Availability

The report notes increasing reports of drug shortages by clinicians and hospitals, including therapies that save and/or sustain life. “During shortages, physicians may have to ration their supplies, delay treatments, or use alternative medications that may be less effective or pose unwarranted side effects,” GAO said. Drug shortages increased each year between 2006 and 2010, with a record number reported in 2010.

FDA’s ability to respond to these shortages is constrained by a variety of management problems, the report continued. “For example, FDA does not systemically maintain and track data on drug shortages and therefore cannot monitor trends. It also lacks a set of results-oriented performance metrics and has not identified drug shortages as an area of strategic importance for the agency.” As a result, coordination is lacking internally as well as with manufacturers to mitigate or prevent strategies.

The report does note some improvement in this area, however. When informed of potential drug shortages in advance, FDA increasingly has prevented them, it said. But “the agency’s approach to managing shortages has been predominantly reactive as it lacked authority to require manufacturers to take certain actions to prevent, alleviate or resolve shortages, such as notifying the agency of an impending or potential shortage.”

This is an area in which FDASIA language could lead to improvement. A provision within the law requires drug makers to notify FDA at least six months in advance if they plan to discontinue making or anticipate a manufacturing interruption for any drug that is life-saving, life-sustaining or used to prevent or treat debilitating diseases or conditions. Meanwhile, the agency has begun detailing more staff and resources to its Drug Shortage Program, the report said.

The agency said in a Feb. 13 blog post that shortages decreased from 251 in 2011 to 117 in 2012.

Timeliness Of FDA Application Reviews

While FDA has its own performance goals setting timeframes for new product application reviews and is meeting “most of its goals,” GAO said, medical device reviews are taking longer. The report does not specifically address missed or extended PDUFA dates for drugs or biologics.

“Industry and consumer groups have also raised issues related to the review process, citing matters such as insufficient communication between FDA and stakeholders, a perceived lack of predictability and consistency in reviews, and inadequate assurances regarding the safety and effectiveness of new products,” it says. GAO calls for continued monitoring of these processes by FDA to improve efficiency and effectiveness.

Elsewhere, the report labels FDA’s procedures for overseeing medical device recalls as unclear. As a result, “FDA officials examining similar situations sometimes reached opposite conclusions on whether recalls were conducted and completed effectively,” the report says. It recommends that FDA improve recall oversight by routinely assessing information on recalls, clarifying procedures for conducting recalls, developing criteria for evaluating recall effectiveness and documenting the basis provided for terminating individual recalls.

GAO separately recommended that FDA clarify and strengthen its device-recall methodology in a June 2011 report commissioned by Sens. Chuck Grassley, R-Iowa, and Herbert Kohl, D-Wis. (Also see "GAO Calls For Reforms In FDA Oversight Of Device Recalls" - Medtech Insight, 27 Jun, 2011.).

The report further urges that FDA conduct more inspections of foreign establishments that manufacture medical products for the U.S. market and use new authority to take a risk-based approach in selecting such sites “to ensure that they are inspected at a frequency comparable to domestic establishments with similar characteristics.”

Lastly, GAO calls on FDA to track applications to market medical products for children.