Sequestration Could Impact Medical Device Reviews

Included in the federal spending cuts $85 billion sequestration that went into effect last week are reductions to the US Food and Drug Administration’s budget, leaving fewer resources for timely medical device reviews. The continuing resolution deal scheduled for March 27th could provide a remedy for funding levels.

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 Fewer resources for timely medical device reviews

On Sunday, Gene Sperling, the White House senior economic official, told “State of the Union” reforms to the tax code and entitlement programs were being discussed, and that Obama was contacting lawmakers in an attempt to negotiate a “common-sense caucus.”

The sequester slashes eight-percent of the US Food and Drug Administration budget, including $71 million to Foods, $39 million to Human Drugs, $17 million to Biologics, $11.3 million to Animal Drugs, and $26.6 million to Devices. FDA public funding will be cut by $206 million, and industry user fees by $112 million. Unless corrected on March 27, the current federal budget continuing resolution limits FDA access to user fees, because appropriations are set at 2012 funding levels.

The new user fees that went into effect this year were intended to speed the medical device review and approval process, however layoffs and furloughs are now likely, resulting in delays in medical device reviews. FDA Center for Devices and Radiological Health (CDRH) 2013 Strategic Priorities will shift as a result of sequestration. Proposed programs, guidance documents, and FDA modernization processes will be halted in the wake of the cuts.

The Obama Administration has urged Congress to allow the US Food and Drug Administration access to the 2013 MDUFA user fees and $41 billion in prescription drug and biosimilar user fees to prevent delays in medical device reviews and other essential programs.

Of course, the cuts don’t stop at medical device reviews. Defense, Homeland Security, Food Safety, Transportation, National Parks, Federal Workers, Education, Congress, Nuclear Security, Tax Collection, Labor, and Healthcare are in the sequestration cross-hairs.

Hospitals, doctors and other Medicare providers will see a two-percent cut in government reimbursements, reducing Medicare spending by $100 billion over a decade. Many medical associations have spoken out against legislators for failing to prevent the Medicare reduction, but experts agree that sequestration is a better option. Obama slated a $400 billion cut in the Medicare budget, and Republicans rallied for even more. 

The sequester was intended to compel Congress to cut the deficit and balance the country’s budget, but since they couldn’t reach a consensus by March 1, 2013, the mandatory sequestration took place. The budget cuts will remain in effect until the end of the fiscal year on October 1, 2013.

About Christopher Ford

Christopher Ford is an expert in global medical device manufacturing compliance with over 20 years of experience, specializing in Class II and Class III medical devices and combination products. He is a certified ISO 13485 Lead Auditor, with over 600 audits under his belt, and he works with organizations of all sizes. His approach to compliance requirements balances customer needs with business objectives, while assuring that all regulatory requirements are met.