First Generic User Fees Proposed By Deputy Commissioner Gottlieb
This article was originally published in The Pink Sheet Daily
Executive Summary
GPhA says it would consider user fees for generics if FDA would endorse legislation to speed generics to the market.
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FDA is proposing improvements to expedite review of all first generics of drugs that have no patent or exclusivity protection. "A goal could be proposed for this class of applications, for example, perhaps committing to first complete action within four months with the appropriate resources to support that," Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb told the Generic Pharmaceutical Association annual meeting in Boca Raton, Fla. Feb. 17. In discussing funding for generic review, Gottlieb suggested that a user fee program could ensure that the Office of Generic Drugs remains on "sound financial footing." "We have seen user fee programs applied to our medical device and new drug programs with great success, enabling not only resources that underwrote scientific and process improvements in how we evaluate applications, but also enabling more collaborative opportunities to get insight into how we can make additional process improvements by working with sponsors," Gottlieb said. While stopping short of directly endorsing such a program for generics, he stressed that representatives from OGD "often tell me, you can always do more with more. There are many opportunities to make additional improvements in our program, especially by working together." At the same time, Gottlieb rejected recent criticism of the agency's newly proposed budget for generic drug review, stating that since fiscal 2001 the agency has doubled the budget of the Office of Generic Drugs and boosted the number of FTEs from 143 to 201. During the House Appropriations/Agriculture Subcommittee's Feb. 16 hearing on FDA's budget request, Reps. Jo Ann Emerson (R-Mo.) and Rosa DeLauro (D-Conn.) criticized the agency for its relatively small increase in funding for OGD. In response to Gottlieb's comments, GPhA said that it would consider user fees if the FDA and the Bush Administration would endorse legislative and other changes that the generic industry believes would speed its drugs to the market. Such legislative changes would likely include the recently introduced, and GPhA supported, bipartisan "Lower PRICED Drugs Act" (1 S 2300), which would block perceived loopholes by, among other things, decoupling the citizen petition review process from the drug review process (2 (Also see "Pediatric Exclusivity Would Be Reduced To Three Months Under Bipartisan Bill" - Pink Sheet, 15 Feb, 2006.)). On this topic, Gottlieb said that FDA is "looking at ways to make additional improvements in our process for handling these petitions, to make sure that they don't inappropriately delay entry of legitimate generic drugs because of inefficiencies in our own process." One example of an improvement in this area is that OGD scientific staff now address most issues raised in citizen petitions and complicated requests for information, removing the burden from review staff, Gottlieb said. The deputy commissioner proposed other upgrades to the agency's review of generic drugs, including working with the generic industry to "develop methods and standards for demonstrating therapeutic equivalence for a range of products for which equivalence cannot" be easily shown. The four examples mentioned were metered-dose inhalers, nasal sprays, topical dermatologics and liposomes. In an effort to allow faster interactions with generic companies, the FDA will also be lifting all restrictions on telephone interactions with the industry, Gottlieb said. The limitations were among the last remaining strictures that the agency had imposed following the generic review scandal of the late 1980s, and the move can be seen as a symbol of the agency's embrace of collaboration with industry. -John Rancourt |