The GDUFA ‘self-identification’ requirement for generic API plants is not a flawed idea says SOCMA’s BDTF after FDA extends registration deadline citing fewer than expected registrations.
Late yesterday the US FDA gave generic drug manufacturing plants an extra two weeks to ‘self-identify’ after revealing that only around 1,700 of the 2,000 expected to register under the Generic drug user fees act (GDUFA) had done so by the original December 3 deadline.
Under the statue , generic drugs and active pharmaceutical ingredients (API) made at plants not registered with the Food and Drug Administration (FDA) by the deadline – now December 18 – will be deemed as misbranded , which means they cannot be exported to or sold within the US.
The idea is that in addition to providing an accurate list of plants required to pay annual ‘user fees’ for inspections, self-registration will help promote transparency within global supply chains and improve the quality of non-branded drugs sold in the country.
The FDA said: “To date, more than 1,700 facilities have self-identified for FY 2013. This figure is below estimates of the universe of generic drug facilities.” The agency added that – based on a comparison with ANDAs submitted since October – not all of the facilities required to register are doing so.
“One out of eight facilities in these recent submissions has failed to self-identify, a trend that, if uncorrected, will result in higher individual facility fee amounts,“ it said, adding it does not want to raise fees as doing so would penalize firms that have already complied.
GDUFA 'self-identification' law not flawed, photo from Shutterstock
John DiLoreto, executive director of the Society of Chemical Manufacturers and Affiliates’ (SOCMA) Bulk Drug Task Force – which helped develop GDUFA – told in-pharmatechnologist.com that although below expectations, the fact 1,700 plants had registered in the time available is encouraging.
“This is the first year of the program and communicating this information to other parts of the globe is a little more difficult than just to the US and Europe. The number is actually quite good for the time allowed for the self-identification process and can only get better.”
“The word is out, but will take time to reach all suppliers. Unfortunately, in the first year there was not much time for this self-identification process. Also, the penalties for failure to self-identify and pay the fee are significant, and should, in themselves, encourage manufacturers to qualify.”
DiLoreto also rejected the idea that the lower than expected registration rate indicates that ‘self-identification’ will not work, arguing that “it is not flawed, but will yield a slightly lower number of sites, as more sites will register even after the process is done.”
He concluded by reiterating that: "We are glad the FDA extended the period to allow the greatest number of companies an opportunity to identification."