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Compliance In Focus
Posted by John Lehmann on Wed, Mar 20, 2013

Sequester and FDA - Potential Impact on Medical Device Industry?

Many government agencies have been vocal regarding the recently passed Sequester that cutsSequester and FDA 1.2 trillion dollars over the next 9 years. One agency has been rather quiet- FDA.

The White House Office of Management and Budget testimony before the Senate declared that the FDA 2013 fiscal year budget will be cut by 210 million dollars between March 2, 2013, and September 30, 2013, which counts for 5% of the 4.1 billion dollar budget of the agency.

How will FDA respond to the cuts and how will that affect the medical device industry?

To begin, unlike other government agencies, FDA has repeatedly confirmed that there is no anticipation of having to furlough its employees as other agencies are planning. However, the agency has been notably understaffed for the past several years. FDA matters, The Grossman FDA Report notes that most of the savings to balance the cuts will come from unfilled or delayed filling of staff vacancies.

Steve Grossman, author of The Grossman FDA Report, also notes that the cuts will delay food inspections and reviews of drugs and devices. Additionally, small cuts here and there may not be as noticeable felt, as in reducing travel and training.

In Medical Devices Today, preview from The Gray Sheet, budget cuts could mean delays in new science and technology, regulatory policy and decision making, which translate into delays of new approvals.

According to the article, FDA Faces Uncertainty with Sequester, Continuing Resolution, FDA will shift priorities, providing less IND (investigational new drug) and NDA (new drug application) applicant with advice and feedback, to allow for approvals that are already close to approval and closer to helping people.

The information available about the Sequester’s affect on the FDA is mostly speculation, as FDA has provided little public information beyond noting that furloughing employees does not seem to be in the cards.

Will the prolonged staffing vacancies and travel cuts result in fewer inspections in 2013? Are there other ways that FDA could respond to budget cuts? Please share your thoughts in this hot industry topic.

Photo Credit: Images_of_Money

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Topics: Sequester, The Grossman FDA Report, FDA, Medical Device Industry


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