PDUFA, GDUFA make 2012 milestone year

2012 is turning out to be a pretty important year for generic drugs, important enough that some of the things happening over the past several months have begged comparison to 1984, probably the biggest milestone year for the industry.


In July, Congress passed, and President Barack Obama signed, the Prescription Drug User Fee Act, which included the Generic Drug User Fee Amendments, known respectively as PDUFA and GDUFA. Following the signing, Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act,” referring to the law that created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.


The amendments create a system of user fees that generic drug companies will pay to the Food and Drug Administration when they apply for approval of a drug. These fees are projected to raise about $299 million per year over five years. That money will go toward hiring extra staff who will help clear the FDA’s estimated backlog of 2,500 generic drug approval applications awaiting review. Many of those applications are for drugs for which multiple versions already exist, as opposed to entirely new generic versions of branded drugs.


The wave of major branded drugs losing patent protection has continued as well. Pfizer’s cholesterol drug Lipitor (atorvastatin calcium) was the most noteworthy example, having gone generic in November 2011 with the introduction of Ranbaxy Labs’ generic version; Ranbaxy’s own 180-day period of market exclusivity, which it received as the first company to successfully file for FDA approval of a generic version of the drug, ended in May of this year, allowing other generic companies to make their own versions. Other major drugs facing patent expiry this year have been Bristol-Myers Squibb’s and Sanofi’s blood-thinning drug Plavix (clopidogrel), AstraZeneca’s psychiatric drug Seroquel (quetiapine), Merck’s respiratory drug Singulair (montelukast) and Takeda’s Type 2 diabetes drug Actos (pioglitazone).


“Right now, there’s plentiful generic opportunities,” IMS Health VP industry relations Doug Long told Drug Store News. “It’s almost a who’s-who list of patent expiries.”


In addition to generic drug makers themselves, retail pharmacies plan to benefit as well. “They generally make more margin for a generic product than they do for a branded product, particularly during the exclusivity period,” Long said.