Following months of negotiations over the law – which allows the FDA (US Food and Drug Administration) to collect more money from manufacturers – the act will for the first time charge generics makers an inspection fee under the new Generic Drug User Fee Act (GDUFA).
Many have hailed the legislation – which now requires all foreign and domestic drug production facilities be inspected – as a much needed step towards harmonisation internationally. The regulator also believes the move means it will cut generics review times down from 30 months to 10 months.
In a response to the news, SOCMA (Society of Chemical Manufacturers and Affiliates) member group Bulk Pharmaceuticals Task Force (BPTF), said: “The GDUFA levels the playing field for domestic pharmaceutical producers by requiring that all foreign and domestic drug production facilities be inspected, a key step in improving the drug supply chain.”
BPTF chair Patty Benson welcomed the changes, adding that the goal has always been to: “hold all players contributing to the US generic drug system to the same inspection standards and enhance the agency’s ability to identify and track registration and contributors involved in each drug product sold in the US.”
Democrat Tom Harkin, chair of the Senate Health, Education, Labour and Pensions (HELP) Committee, who drew up the bill, told congress the move is a bid to bring the regulator’s global drug supply chain authority into the present day.
The main debate for passing the law came from the Congressional Budget Office (CBO), who estimated the bill will increase the federal deficit by $247m (€198m) over the next decade.
However, with the FDASIA (Food and Drug Administration Safety and Innovation Act) vying for a tighter grip on the global supply chain, the CBO was satisfied the new act could reduce spending by up to $750m over the same period.
And with a further $299m per year coming from generic drugmakers, it seems the decision is a “win-win,” as Harkin put it.
A prescription for success?
The amendment also included the reauthorisation of the Prescription Drug User Fee Act (PDUFA) which will require drugmakers to pay fees totalling $4.1bn over the next five years.
PhRMA (Pharmaceutical Manufacturers’ Association) lent its support to the act. Senior VP Matthew Bennett said: “By reauthorizing PDUFA, members of both sides of the aisle have taken an important step forward toward providing the FDA with much-needed resources and management tools to support patient safety and to promote innovation through increased consistency and efficiency in FDA’s science-based human drug review program.”
After being passed by the Senate attention now turns to the House which is due to vote on its version of the bill next week.