GDUFA reduces wait time for generics
For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.
Currently, according to the Generic Pharmaceutical Association, it takes 31 months for the FDA to review an electronically submitted abbreviated new drug application, which has resulted in a backlog of more than 1,000 applications awaiting FDA approval. Under the recently negotiated Generic Drug User Fee Act, however, the wait time will be reduced by more than two-thirds, to 10 months. The act, for which the FDA released guidelines last month, will provide the agency with nearly $1.5 billion in supplemental funding through user fees and will effectively eliminate the application backlog by the end of fiscal year 2017, according to the GPhA.
In addition, GDUFA will help improve the safety of the country’s drug supply. Currently, according to the GPhA, almost 40% of prescription drugs in the United States are imported, while up to 80% of the active pharmaceutical ingredients in those drugs are sourced abroad. Still, according to the Government Accountability Office, the FDA was able to conduct good manufacturing practice inspections at 11% of the foreign sites in its database, compared with 40% of domestic sites. GDUFA will help increase the number of sites inspected.
“The Generic Drug User Fee Act is a milestone for the generic drug industry and a major win for American healthcare consumers,” GPhA president and CEO Ralph Neas said. “This program, as negotiated, will result in expedited access to low-cost, high-quality generic drugs for Americans, and will further safeguard the quality and accessibility of our nation’s drug supply.”
80% of drug shortages are injectables, 80% are generics
One issue that is unlikely to see resolution this year is the growing problem of drug shortages. As of October 2011, the Food and Drug Administration and the American Society of Health Systems Pharmacists found shortages of 168 drugs. According to healthcare analytics firm IMS Health, while this represents a small and highly concentrated portion of the overall drug market, it includes a number of critical drugs used to treat cancer, infections, cardiovascular disease, central nervous system disorders and pain. In addition, more than 80% of these 168 drugs are injectables and more than 80% are generics.
IMS VP industry relations Doug Long said one cause for the shortage was efforts by generic drug makers to move up the value chain and develop more specialized therapies. Many of the drugs experiencing shortages — some of which are 20 to 30 years old — are no longer profitable and thus no longer made. “I think the progress that we’ve made is identifying the causes of [shortages],” Long told Drug Store News.
Meanwhile, the Obama administration sought to address the problem with a rule issued last month that would require manufacturers that are the sole producers of certain drugs to report any interruptions in manufacturing to the FDA. The Generic Pharmaceutical Association also called for the creation of a new initiative to gather current and future supply information from various stakeholders for certain products and use the information to identify current and potential supply gaps, focusing on products with an expected shortage time longer than 90 days. IMS also recommended the creation of an early warning system for drug shortages that would include systematic risk identification, continuous long-term demand forecasting, creation of a supply volatility index and comprehensive predictive modeling.
Generics face new and long-standing issues
In the Feb. 7, 2011, issue, Drug Store News named three major issues that would define 2011 for the world of generic drugs. Those issues were drug safety, generic user fees and patent settlements.
All three managed to surface in some form over the course of the year. Drug safety became an issue with Ranbaxy Labs’ planned launch of a generic version of the blockbuster cholesterol- lowering drug Lipitor (atorvastatin), when analysts speculated that long-standing issues with two of its manufacturing plants in India would thwart its plans to launch the drug on Nov. 30, as scheduled. But the company partnered with New Brunswick, N.J.-based manufacturer Ohm Labs to make the drug and received FDA approval in the evening of Nov. 30, just hours after Watson Pharmaceuticals launched its authorized generic. Generic user fees rose to particular prominence at the end of the year when the FDA released guidelines for the Generic Drug User Fee Act, and based on that, there’s a good chance that further progress will be made in Congress and at the FDA.
Patent settlements became an issue as well, with attacks on so-called “pay-for-delay” deals by the Federal Trade Commission and members of Congress, and given that they have been a perennial issue, there’s reason to suspect they will become one in 2012 as well.
This year, generic drug makers again will face a number of issues and challenges. These include perennial issues like patent settlements and biosimilars (see stories here and here), as well as long-standing issues that may become more prominent, such as the patent cliff (see story here). Drug shortages have received a lot of attention from the government and the media, which is a good thing, but experts say the problem is unlikely to find substantial resolution despite efforts by the Obama administration to address it (see story here). Meanwhile, the negotiation and release of guidelines for GDUFA mean generic user fees are likely to get some attention as well (see story here).