FDA to Recognize Review Process from Eight European Agencies

The US Food and Drug Administration (FDA) has been on the ball when it comes to drug policy, not only as it relates to the opioid crisis in the US but to speed up the approval process in general.
Case in point, on Tuesday (October 31) the FDA announced it will acknowledge eight different regulatory agencies in Europe “capable of conducting inspections,” beginning Wednesday (November 1). The list includes Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK.
FDA commissioner Scott Gottlieb said in the release that due to the globalization of drug development, there is a benefit to this kind of partnership between regulatory agencies.
“There is much to be gained by partnering with regulatory counterparts to reduce duplicative efforts and maximize global resources while realizing the greatest bang for our collective inspectional buck,” Gottlieb said in the  statement. “By partnering with these countries we can create greater efficiencies and better fulfill our public health goals, relying on the expertise of our colleagues and refocusing our resources on inspections in higher risk countries.”

Globalization of pharma development pushes FDA to join forces with European agencies

This decision comes with the rationale that drug development has expanded from being located in the market it later intends to sell the product. Partnerships between companies all over the world have elevated the degree of difficulty for regulation.
The push to speed up the FDA approvals has been criticized due to the agency already producing a speedy process. The potential danger of allowing a harmful product into the market could backfire on this request.
“Some drugs approved in the U.S. are either fully manufactured overseas or made in the U.S. but contain some foreign ingredients,” the FDA wrote.
Dara Corrigan, the FDA’s acting deputy commissioner for global regulatory operations and policy, said the FDA will now rely on the data collected by the selected eight agencies.
Back in June, the European Commission officially acknowledged the FDA was capable of conducting good manufacturing practices (GMP). Thanks to this results recognition, both the FDA and the EU can avoid conducting duplicates of tests for products.
“[T]his prioritization of inspections will help identify potential drug quality problems more quickly and prevent poor quality drugs from entering the US market,” the FDA wrote.

Reduction of foreign trips and impact of costs

The FDA will be conducting “fewer routine manufacturing facility inspections… in countries deemed capable” according to FDA press officer Lyndsay Meyer. The FDA estimated each foreign trip carried an average $57,600 price tag, Meyer told INN in an email response.
“The percentage of the field medical product budget authority used to fund foreign drug and device establishment GMP inspections was approximately 29 percent,” the FDA indicated in its 2016 annual report. According to the report, 29 percent represents approximately $77,224,000 used for foreign inspections.
Meyer stressed the agency, as well as the European ones, reserve the right to inspect “at any time and in any country,” despite this expected reduction.
“The FDA will continue to perform inspections of facilities manufacturing certain drugs, like veterinary medicines and vaccines, because these are not yet included in the scope of FDA’s capability determinations” Meyer added. “FDA will also continue to inspect facilities as necessary in evaluating drug applications for marketing approval.”

Trump’s words on the FDA cause action by the agency

Earlier this year US president Donald Trump expressed he wanted a reduction in the approval process for the FDA “[O]ur slow and burdensome approval process at the Food and Drug Administration keeps too many advances… from reaching those in need,” Trump said during a speech at a joint session of Congress in March.
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Securities Disclosure: I, Bryan Mc Govern, hold no investment interest in any of the companies mentioned.