Speedy delivery: Bringing generics to market faster

As the Food and Drug Administration begins to explore ways to improve its user-fee program for generic drugs, the Generic Pharmaceutical Association and its members have weighed in with suggestions on how to shore up the law to ensure that it helps bring generics to market faster and provides benefits across the entire healthcare system.

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Expediting the approval of new generics, the association and its members contended, will have a positive impact on patient care and help control the nation’s healthcare spending.



“GDUFA is a historic achievement for both the FDA and the generic pharmaceutical industry,” GPhA president and CEO Ralph Neas said last month as the FDA was preparing to hold a public hearing on moving GDUFA forward in fiscal 2015.



“Generic drug savings are a boon for patients, taxpayers, businesses, government and all who rely on access and choice when it comes to more affordable medicine,” he said. “In 2013 alone, generic drugs were responsible for $239 billion in savings for the U.S. health system.”



Noting that generic drug makers provide all of the funding for GDUFA — $300 million in 2013 — Neas and GPhA SVP regulatory affairs David Gaugh, who testified at the FDA hearing, said that for the program to be successful it must be implemented in a manner that reflects the realities of the marketplace and continues to provide incentives for the development of new generic medications.



“Since the implementation of GDUFA, all informal contact between reviewers and applicant has ceased and has not been replaced with any meaningful alternative. The result has been a major reduction in transparency,” Gaugh said.



 Enacted in 2012 as an extension of the FDA’s 20-year-old Prescription Drug User Fee Act, GDUFA is designed to get new generics on the market quicker, while also reducing drug makers’ expenditures. The law requires generic manufacturers to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. FDA officials said these added revenues eventually would enable the agency to reduce the backlog of pending new drug applications, cut the average time required to review generic drug applications for safety and increase risk-based inspections.



Despite its promise to speed up generic approvals, drug makers said that so far the law has had the opposite effect.



“Since the implementation of GDUFA, there have been some improvements, but in most areas GDUFA was designed to address — and especially in the timely handling of new drug applications — things are measurably worse than they were before the FDA began receiving hundreds of millions of dollars a year in new user fees,” John Ducker, president and CEO at generic drug maker Fresenius Kabi USA, told the FDA panel.



“Generic medicines have saved U.S. payers and patients about $1.5 trillion over the last 10 years. In the years ahead, savings like this will only be possible by more timely approval of generic medicines,” he said.



Where GDUFA has succeeded, GPhA and its member said, has been in prioritizing approvals of generic drugs that can provide the greatest public health benefits. For instance, Ducker said that in some cases, Fresenius Kabi’s products have been approved in a few weeks, enabling the company to help alleviate critical shortages.



However, he stressed, approval times for drugs that are not in short supply tell a different story.



Fresenius Kabi, for example, has more than 50 abbreviated new drug applications pending review. While the company has not targeted a date to bring these products to market, Ducker said he fears long delays because of the FDA’s plans to begin focusing on new submissions in order to meet what it said are obligatory performance metrics.



Proponents of generic drugs said that the key to making GDUFA work the way it was designed is to increase the lines of communication betweeen the FDA and drug makers. Regulators’ concerns, they stressed, can only be addressed when the drug companies are aware of them.



“GPhA believes a significant portion of the issues identified during the technical reviews can be classified as easily correctable deficiencies and communicated to applicants during the review process,” Gaugh said. “The industry is able to respond to ECDs in a short period of time — on the average, less than five days upon receipt of the ECD — which can facilitate the review process and enhance efficiencies for both the agency and industry.”