Managed Care - February 2008 - (Page 21) MEDICATION MANAGEMENT The idea behind QBR is to provide preemptive information to drug manufacturers in question form that facilitates a subsequent review of products and processes. The reviews assess formulation and manufacturing variables, set regulatory specifications, and determine the safety and quality risk associated with manufacture and design. “That way we maximize efficacy, improve safety profiles, and enhance the chemistry, manufacturing, and controls process,” says Buehler. Although the Generic Pharmaceutical Association (GPhA) has no problem with this review process change, Kathleen Jaeger, president and CEO is concerned that GIVE is to some degree placing the cart before the horse. It fails to address the “serious legislative and regulatory issues that must be addressed to yield a true increase in the number of affordable generics brought to market,” she says. “The FDA has tinkered with programs and initiatives designed to increase efficiency, but there are other important issues that could result in a true increase in the number of affordable generics brought to market,” says Jaeger. They include the citizen petition process, the quality of scientific consults, communication within the FDA and with manufacturers, and the structure and accountability of the entire office of generic drugs, she says. If the FDA is notified by the patent holder that it is suing the generics manufacturer, the FDA imposes a 30-month stay of approval. If the 30-month stay expires and no settlement has been made, the FDA can issue a full approval of the application. But if the generics manufacturer should eventually lose the suit, it may be held responsible for damages against the RLD holder, says Buehler. Generics manufacturers worry that this change will inhibit at-risk launches. And GIVE may provide a further incentive for RLD manufacturers to adopt methods of extending the life cycles of their older drugs, such as novel drug delivery systems and/or new disease indications. User fee program The GIVE program, which combines elements of several existing programs, does not address the fundamental problem of OGD underfunding, say GPhA officials. OGD now receives about $30 million a year, a fraction of the more than $400 million allocated to the Office of New Drugs. About half of that comes from user fees paid by the makers of brandname medications when they submit applications to market new drugs. The GPhA recognizes that the Agency needs more staff and resources to meet its workload. To provide increased resources and enhance the generics approval process, GPhA and OGD have entered into discussions about creating a user fee program or makers of generic drugs, similar to the one now in place for branded drug manufacturers. Any such program for the makers of generics would have to be approved by Congress. If a generics user fee program is to guarantee that generic drugs are reviewed and approved more quickly, it should “include robust performance measures, a high degree of certainty in the review and approval process, recruitment and retention of reviewers, and it should close barriers to public access to generics. If the FDA and Congress do not address these long-existing fundamental issues, we will be doing little to help consumers get the affordable medicines they needs,” says Jaeger. MC Re-ordering priorities A second significant change reflected in GIVE is a re-ordering of ANDA review priorities. GIVE places a new priority for “first generic” products for which there are no extant blocking patents or exclusivity protections on RLDs. Those ANDAs will be identified as such at the time of submission. The aim is for the FDA to speed up the path to commercialization for products that can enter the market right away, say FDA officials. Under FDA rules, tentative approvals are awarded to generic products that have been deemed to meet the safety and efficacy standards necessary for marketing. The agents cannot be awarded full approval for sale because they would at that time be in violation of a patent on an existing RLD. FEBRUARY 2008 / MANAGED CARE 21
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