Drug Topics - March 10, 2008 - (Page 12) 12 DRUG TOPICS MARCH 10, 2008 www.drugtopics.com > > > Latebreakers In Depth GPhA sets sights on increasing access to generic medicines in 2008 Sandra Levy C itizen petitions … Inadequate inspection rewith FDA to create an effective and meaningful user sources … Barriers put up by brand-name fee program, an agreement has yet to be reached. companies … The Food & Drug Ad“As we saw with the brand pharma indusministration’s Office of Generic Drugs try, negotiations aren’t easy. They take a lot (OGD) needs to address these and other of time and at the end, FDA granted the longstanding issues that are blocking timely brand companies very specific performaccess to affordable medicines. ance goals in exchange for the investment This message was delivered by Kathleen of resources. We, too, are looking for simiJaeger, president/CEO of the Generic Pharlar assurances of predictability of review maceutical Association to a packed room of and approval.” attendees at GPhA’s annual meeting, held recently in Boca Raton, Fla. Push for biogenerics “Generics are the right choice for better Kathleen Jaeger GPhA is intent on bringing biogenerics to told GPhA health. This is the message that GPhA has consumers, Jaeger asserted. While she apmembers that taken to the Congress, to state capitols, and plauded President Bush’s mention of bioFDA needs to to the presidential campaigns. It’s also a mesgenerics in his budget submission to Conaddress longsage we consistently deliver to the White standing issues. gress, Jaeger said, “the devil is in the details. A House and the FDA, because when you look pathway (for the approval of biogenerics) at the fact that generics save the federal government filled with roadblocks to access, including excessive and consumers tens of billions of dollars each year, it market exclusivities, is an empty promise for the would only seem logical that our leaders should accountless patients who need these affordable life-savknowledge that generics are indeed the right choice,” ing medicines.” said Jaeger. Jaeger added that the Biotechnology Industry Organization and the Pharmaceutical Research and ManuNeed faster reviews facturers of America are pushing for a pathway that Acknowledging that OGD’s reviewers and scientists would entail “unprecedented and excessive market exwork hard every day to review and approve generic apclusivities and patent protections to ensure their moplications, Jaeger said that while they deserve more nopolies. We believe members of Congress will recogfunding, “increased resources alone will not fix the unnize that cutting such a deal will put brand profits derlying problems of access. There must be certainty in before the needs of patients.” the review process.” Jaeger said that GPhA will continue to inform ConPointing out that in 2005 the brand drug industry gress that it is possible to foster innovation and comheld nearly 2,200 meetings with the FDA, Jaeger said petition without needlessly jeopardizing access. the generic industry had fewer than 10 meetings with Finally, during a Q&A session, Jaeger addressed the agency. “If we aren’t able to communicate more efGPhA’s need to halt state “carve out” legislation that fectively, safe and affordable medicines simply won’t bars generic substitution for various therapeutic classget to consumers faster,” Jaeger asserted. es of medicines. “Who is pushing this legislation and While Jaeger commended Congress for taking an why?” It’s the brand companies. A lot of their prodimportant step last year in helping to curb the brand ucts will be expiring this year. We have a sound sciindustry’s abuse of the citizen petition process, Jaeger ence-based approval system. We need to explain to said passing a mandate “doesn’t always mean problem the policy makers in all the states that when FDA apsolved. FDA needs to implement this mandate and proves a (generic) product that is a therapeutic equivCongress must provide the agency with the necessary alent, that it means the same medicines (as the brand resources to do so.” product) and the same clinical results. We have to Jaeger went on to say that while this past summer push back on the misinformation campaign out the generic industry entered into a good faith effort there,” said Jaeger. DT Photo: Sandra Levy http://www.drugtopics.com
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