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Despite record investments in research and development, many of today's scientific breakthroughs have not been transferred into safe and effective medical treatments, according to top U.S. health officials at the 10th annual FDA Science Forum.
FDA officials reported progress on key International Conference on Harmonisation (ICH) initiatives at a public meeting yesterday to prepare participants for the ICH Steering Committee and Experts Working Groups meetings slated for June 7-10 in Washington, D.C.
The FDA rejection of Barr Pharmaceutical’s bid for OTC status for its controversial Plan B emergency oral contraceptive was based on scientific analysis of the data, and not political pressure, according to a top FDA official who pointed to a possible future approval.
As part of its recent push to promote generic drugs, the FDA has compiled a chart that shows daily drug costs can fall by 16 percent when generics are used instead of brand drugs.
PhRMA is urging the FDA to implement an administrative penalty to discourage generic firms from missing deadlines for submitting notifications that start the 45-day clock for drugmakers to file patent-infringement lawsuits.
Arguing that drug exclusivity is not a right that can be transferred, Pfizer contends the recent deal between Teva Pharmaceutical and Alpharma to share a portion of Alpharma’s 180-day marketing exclusivity period for a version of Pfizer’s epilepsy drug Neurontin (gabapentin) violates federal drug patent laws.
The FDA should add regulatory language to rules governing brand-generic competition that would expressly require a brand firm to correct or delete patent information when a court order requires such a patent change, the Generic Pharmaceutical Association (GPhA) said in comments suggesting changes in FDA drug patent rules.
The FDA has sent a warning letter to an Illinois drugmaker for a journal advertisement that did not contain pertinent risk information about an anti-organ rejection drug; the ad also was not properly submitted for postmarketing reporting requirements.