US Congressman Henry Waxman has vowed to fight to promote competition within the pharmaceutical industry, adding that the US Food and Drug Administration's 32-month approval time for generic drugs is "inexcusable".
Speaking at the World Generic Medicines Congress in London, UK, Waxman discussed the amended Federal Food, Drug, and Cosmetic Act, which allows pharmaceutical companies to file for abbreviated new drug applications to seek FDA approval of generic drugs.
The backlog of applications has been increasing every year, meaning that high-priced, brand-name drugs get longer exclusivity in the market.
But Waxman insisted that this situation is about to change, "We hope to change the law so the FDA can consider these generic drugs for approval earlier."
However, Asish Kakabalia, head of pharmacy and GSL sales and business development at Wockardt, and delegate at the congress, said that the FDA is simply trying to filter out drug companies with low standards.
"Everybody is trying to get approval these days. Imagine going to a free exhibition; anybody who's anybody could turn up. This is why the FDA is so stringent with the process of approving drugs."
The news follows Waxman's decision to amend the Patient Protection and Affordable Care Act signed by President Obama on 23 March 2010.
The new law now allows brand-name drug seven years of market exclusivity, instead of 12 years, as originally stated in the proposal.
SOURCE:Pharmaceutical-technology
