Citizen petitions ... Inadequate inspection resources ... Barriers put up by brand-name companies ... The Food & Drug Administration's Office of Generic Drugs (OGD) needs to address these and other longstanding issues that are blocking timely access to affordable medicines.

Kathleen Jaeger told GPhA members that FDA needs to address longstanding issues.

"Generics are the right choice for better health. This is the message that GPhA has taken to the Congress, to state capitols, and to the presidential campaigns. It's also a message we consistently deliver to the White House and the FDA, because when you look at the fact that generics save the federal government and consumers tens of billions of dollars each year, it would only seem logical that our leaders should acknowledge that generics are indeed the right choice," said Jaeger.

Acknowledging that OGD's reviewers and scientists work hard every day to review and approve generic applications, Jaeger said that while they deserve more funding, "increased resources alone will not fix the underlying problems of access. There must be certainty in the review process."

Pointing out that in 2005 the brand drug industry held nearly 2,200 meetings with the FDA, Jaeger said the generic industry had fewer than 10 meetings with the agency. "If we aren't able to communicate more effectively, safe and affordable medicines simply won't get to consumers faster," Jaeger asserted.

While Jaeger commended Congress for taking an important step last year in helping to curb the brand industry's abuse of the citizen petition process, Jaeger said passing a mandate "doesn't always mean problem solved. FDA needs to implement this mandate and Congress must provide the agency with the necessary resources to do so."

Jaeger went on to say that while this past summer the generic industry entered into a good faith effort with FDA to create an effective and meaningful user fee program, an agreement has yet to be reached. "As we saw with the brand pharma industry, negotiations aren't easy. They take a lot of time and at the end, FDA granted the brand companies very specific performance goals in exchange for the investment of resources. We, too, are looking for similar assurances of predictability of review and approval."

Push for biogenerics

GPhA is intent on bringing biogenerics to consumers, Jaeger asserted. While she applauded President Bush's mention of biogenerics in his budget submission to Congress, Jaeger said, "the devil is in the details. A pathway (for the approval of biogenerics) filled with roadblocks to access, including excessive market exclusivities, is an empty promise for the countless patients who need these affordable life-saving medicines."

Jaeger added that the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America are pushing for a pathway that would entail "unprecedented and excessive market exclusivities and patent protections to ensure their monopolies. We believe members of Congress will recognize that cutting such a deal will put brand profits before the needs of patients."

Jaeger said that GPhA will continue to inform Congress that it is possible to foster innovation and competition without needlessly jeopardizing access.

Finally, during a Q&A session, Jaeger addressed GPhA's need to halt state "carve out" legislation that bars generic substitution for various therapeutic classes of medicines. "Who is pushing this legislation and why?" It's the brand companies. A lot of their products will be expiring this year. We have a sound science-based approval system. We need to explain to the policy makers in all the states that when FDA approves a (generic) product that is a therapeutic equivalent, that it means the same medicines (as the brand product) and the same clinical results. We have to push back on the misinformation campaign out there," said Jaeger.