SOCMA’s Bulk Pharmaceuticals Task Force has long been an advocate and supporter of the Food and Drug Administration’s (FDA) Generic Drug User Fee (GDUFA) program and its goal to consistently perform risk-based inspections of both U.S. and foreign drug manufacturing facilities. But concerns were recently raised when a memo from the Department of Health and Human Services disclosed a 40 percent decrease in the number of inspections of U.S. drug facilities in 2014 and 2015 – a move that could significantly impact the generic active pharmaceutical ingredient (API) manufacturers the Task Force represents.
To address the issue, BPTF sent a letter on May 27 to the FDA, voicing its concern with the agency’s plans to reduce U.S. facility inspections and elevate the number of foreign facility inspections it performs.
The user-fee program, signed into law in 2012, provides additional funding to help safeguard the nation’s drug supply and establish greater scrutiny of drug manufacturing in high-risk regions of the world. Through GDUFA, the federal government can increase its speed for approval of lifesaving medicines, reduce drug shortages and improve safety throughout the drug supply chain in the U.S. BPTF was a key stakeholder in the GDUFA negotiations and supported the $300 million per year fee structure that provides FDA with the financial resources it needs to inspect foreign drug manufacturing facilities with the same frequency as domestic facilities. What BPTF never expected was a decrease in U.S. facility inspections as part of the process.
Under GDUFA, FDA is tasked with performing good manufacturing practices (cGMP) inspections every two years for generic active pharmaceutical ingredient (API) and generic finished dosage form (FDF) manufacturers. The agency also uses a risk-based assessment in determining the length of time between inspections, guided by a two-year cycle for FDF product sites and a three-year cycle for API sites.
In a recent report to the President and Congress, FDA estimated in 2013 that only 80 percent of domestic API facilities had received surveillance inspections in the last three years. Consequently, if the inspection rate is reduced by 40 percent, then more than half of the domestic API manufacturers would not receive an inspection within the three-year cycle – a requirement for marketing reauthorization in many pharmaceutical producing countries like the EU, Australia and Canada. This could result in the drug product not receiving timely renewal, a problem that BPTF members and their customers are already experiencing.
Another issue of concern for BPTF is a lack of uniformity in FDA inspections across different geographical areas of the country. For example, some inspections don’t appear to be based on risk because they are happening so infrequently, while other facilities with excellent cGMP histories are being inspected almost yearly.
In its letter, BPTF asked the FDA to ensure that U.S. manufacturing facilities are inspected within a three-year window and that the frequency of inspections continue to be risk-based without regard for geographical location, all of which they agreed to in their commitment to GDUFA.
While GDUFA implementation is a difficult task, it is important not to unnecessarily endanger the safety of the drug supply chain by reducing inspections of U.S. facilities. Answers on the FDA’s approach to foreign and domestic inspection frequency will provide reassurance that the agency can meet the goals established in negotiations with generic API manufacturers.