GPhA President And CEO Issues Statement On FDA FY09 Budget Proposal, USA
"The shared goal of the FDA and the generic pharmaceutical industry should be to bring safe, effective and affordable medicines to consumers in a timely manner.
"We welcome the news that the Administration has endorsed the fact that FDA has the scientific expertise to establish a safe and workable regulatory approval pathway for biogenerics. Now the Administration needs to join with the more than 70 organizations representing businesses, labor, consumers and older Americans, as well as a distinguished group of governors, who are asking for FDA to provide timely access to biogenerics. A pathway filled with roadblocks to access, including excessive market exclusivity provisions, is an empty promise for countless patients who need these affordable life-saving medicines.
"This year's budget proposal also includes industry user fees. As we said last year, our industry is willing to establish a user fee program to accomplish this goal, but to truly benefit consumers, the program must be effective and remove longstanding barriers to access.
"We all agree that the dedicated FDA scientists and reviewers should have the resources they need to do their jobs. But what consumers need is for the FDA to address the core fundamental issues that are blocking timely consumer access to affordable generics. These core issues have been around for more than a decade and include the citizen petition process, scientific consults, enhanced communication, more inspection resources, accountability and structure of the Office of Generic Drug Program.
"Given the savings received by the federal government from generic medicines, we call on Congress to continue to provide sufficient supplemental funding to the FDA's Office of Generic Drugs. Congress took a positive step forward in providing FDA with a $6 million FY'08 increase in appropriations for FDA's Office of Generic Drugs. The return on investment from increased funding and addressing longstanding core issues will pay significant and long-lasting dividends to the federal government as well as for all Americans-individual consumers, employers, and state governments.
"Bringing generic medicines to market in a timely manner is a win-win for the federal government, the generic industry and, most of all, consumers. In 2008, we should all work together to reach our shared goal of increased access by providing supplemental funding for the Office of Generic Drugs; enacting legislation to create a workable approval pathway for biogenerics; approving free trade agreements, like the most recent free trade agreement with Peru; and removing longstanding barriers to access such as authorized generics and citizen petitions."
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 63% of the total prescriptions dispensed in the United States, but only 20% of all dollars spent on prescription drugs.
Generic Pharmaceutical Association
GPhA preºedinte ºi CEO declaraþie pe probleme de FDA FY09 o propunere de buget, SUA - GPhA President And CEO Issues Statement On FDA FY09 Budget Proposal, USA - articole medicale engleza - startsanatate