FDA plans program to increase availability of generic drugs
WASHINGTON The Food and Drug Administration has outlined a program that in theory will increase the number of generic drugs available to consumers and healthcare providers. The program will be titled GIVE, the Generic Initiative for Value and Efficiency.
As part of GIVE, the FDA will revise the review order for certain drug applications. For example, first generic products, for which there are no blocking patents or exclusivity protections on the reference-listed drug, are identified at the time of submission for expedited review. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster.
The president of the Generic Pharmaceutical Association, Kathleen Jaeger, was not impressed with the announcement made by the FDA. “While we all share the goal of increasing efficiency in the generic approval system, another initiative, in name only, simply will not get the job done. 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.
For years, the Agency has tinkered around the edges with programs and initiatives designed to increase efficiency but have proven to yield little in the way of significant results. There are serious legislative and regulatory issues that must be addressed to yield a true increase in the number of affordable generics brought to market. The generic industry stands ready to work with the Agency in tackling these issues to increase consumer access. That’s why we have entered into good faith efforts with the FDA to create a meaningful user fee program that truly results in timely generic access.”
The FDA did approve over 30 percent more generic products in fiscal 2007 over last year, for a total of 682, which is a record for the agency.
FDA increases potency of levothyroxine products
WASHINGTON The Food and Drug Administration is strengthening the potency specifications for levothyroxine sodium to ensure the drug retains its potency over its entire shelf life.
The agency is increasing the specifications from a 90 to 110 percent potency range to a 95 to 105 percent range. The percent ranges were changed following concerns about the product by healthcare professionals and patients.
Data taken by the FDA showed that some of the levothyroxine products like blister packs degrade quicker than other package types. Also, some of the strengths have been shown to degrade more rapidly than others.
Manufacturers and marketers have two years to comply with the revised specification. Levothyroxine sodium products are used by over 13 million patients.
FDA to review heart problems from osteoporosis drugs
WASHINGTON The Food and Drug Administration is looking at new safety data on reports of atrial fibrillation in patients taking bisphosphonates.
Bisphosphonates are used to treat osteoporosis. The FDA is looking into the issue after a study in the May 3rd issue of the New England Journal of Medicine reported increased rates of serious atrial fibrillation in patients taking Fosamax and Reclast.
The FDA has performed an initial review and found that there was not a large enough group of people who were at risk for atrial fibrillation and would not as of right now ask for healthcare professionals to change their prescribing habits or to tell patients to change their use of the drugs.
The agency is seeking additional data to perform an in-depth review of the issue that could take up to one year to conclude.