SOCMA’s (Society of Chemical Manufacturers and Affiliates) Bulk Pharmaceutical Task Force has written a letter to the US FDA taking issue with what may amount to a 40% drop in domestic API inspections for FY 2015.
The task force is concerned that such a reduction would cause more than half of domestic API manufacturers to be penalized under GDUFA (Generic Drug User Fee Act).
“If the inspection rate is reduced by 40%, this could cause over half of domestic API manufacturers to fail to receive an inspection within the 3-year cycle. We wish to bring it to the agency’s attention that such a situation would significantly penalize the most cGMP compliant API manufacturers as well as their customers, the manufacturers of the finished dosage form drug products,” John DiLoreto, Executive Director of the Bulk Pharmaceutical Task Force, said in the letter to the agency.
DiLoreto told in-Pharmatechnologist.com the problem is that industry is paying additional money for generic user fees to increase inspections and create parity between domestic and foreign suppliers, but the agency seems to be creating this parity by raising foreign inspections and decreasing domestic inspections.
According to the FDA’s FY 2015 budget justification , foreign GMP inspections would rise from 604 to 843 inspections from FY 2013 to FY 2015, whereas domestic GMP inspections would fall from 967 to 591 over the same period.
“One of our main concerns in GDUFA is that we wanted there to be parity between domestic and foreign but not” at the expense of domestic inspections, DiLoreto told us. He also noted that currently there are some domestic facilities being inspected every 18 months and without a risk-based approach, which is what the agency had initially called for.
“We would also like to make the Office of Generic Drugs aware that in contrast to the above, some other API manufacturing sites with excellent cGMP histories are still receiving surveillance inspections that are being performed with a frequency that appears not to be risk-adjusted; in fact inspections are being conducted almost yearly,” DiLoreto writes to the FDA.
“We’ve tried to get a response from FDA over the phone but didn’t get a response,” DiLoreto told us, explaining the need for the letter.
The BPTF “is asking the agency to ensure that, in conformance with its obligations expressed in the GDUFA Commitment Letter, the frequency of inspections for any domestic API manufacturer does not exceed three years, and that the frequency of surveillance inspections of such facilities is not unduly influenced by geographical location in the USA,” DiLoreto concludes in his letter.
The FDA did not respond to a request for comment on the letter or the expected drop in inspections.