House Committee Questions FDA Oversight of China, India Manufacturing Facilities
Posted 21 December 2015 | By
Members of the House Committee on Energy and Commerce are calling on the Government Accountability Office (GAO) to investigate whether the US Food and Drug Administration (FDA) is properly overseeing the pharmaceutical supply chain, particularly in China and India.
Reps. Fred Upton (R-MI), Frank Pallone (D-NJ), Tim Murphy (R-PA) and Diana DeGette (D-CO) acknowledge FDA’s work on meeting the rising demands of more foreign active pharmaceutical ingredient (API) and finished-dose manufacturers in India and China, though they remain “concerned that there is still inadequate oversight with regard to these foreign drug plants, not to mention an unequal playing field compared to US drug manufacturers that are subjected to more frequent and rigorous inspections.”
As a Focus review from November shows, India has seen an increasing number of Form 483s and warning letters from FDA in recent years, particularly with regard to data integrity issues. And FDA has also been tracking down issues in Asia, with the recent addition of three Asian companies to its import alert list, which now includes 21 more foreign manufacturing sites in 2015. In total, FDA has barred 38 plants in China from exporting some or all of their products to the US because of manufacturing violations, according to the representatives.
And perhaps compounding the issue of keeping up with Chinese and Indian growth in manufacturing: FDA has very limited resources in both of those countries to inspect facilities (some reports cite a total of two FDA inspectors in China and about a dozen in India).
Due to these persistent concerns, the representatives are calling on GAO to determine:
- How FDA has implemented risk-based inspections in foreign facilities (as required by the Food and Drug Administration Safety and Innovation Act from 2012)?
- What criteria did FDA identify as necessary for establishing its risk-based schedule? And when did this schedule go into operation?
- How many inspections of foreign facilities been conducted over the last five years and how does this compare with domestic inspections?
- What is the status of FDA’s staff dedicated to foreign inspections?
- How many inspections have FDA’s foreign offices conducted and what are their relationships like with foreign regulators and manufacturers?
- Why has FDA closed some of its foreign offices, particularly ones opened a few years ago?
- What’s FDA’s plan for filling vacancies in these foreign offices and what accounts for the delay in implementing recommendations made by GAO five years ago?
Energy and Commerce Letter to GAO