FDA releases draft paper on pilot program for drug naming
WASHINGTON The Food and Drug Administration has released a draft paper stating some of the concepts the agency is considering for a new two-year pilot program beginning in 2009 that will solve the problems of similar sounding drugs on and about to reach the market. The FDA is releasing the paper in advance of a public meeting scheduled to discuss the topic on June 5 and 6.
The pilot program will be designed to allow drug companies to volunteer to evaluate proposed proprietary names and submit the data for review to the Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research, as appropriate. In the pilot program, CDER and CBER will evaluate the safety and promotional implications of submitted drug names. If a name seems prone to cause confusion, the relevant center “will not recommend its approval for use in the market and will request the applicant propose an alternate name for evaluation,” the draft says. “Any preventable risk of error that can be identified prior to drug approval should be addressed.”
For example, applicants are advised to avoid proprietary names that incorporate or suggest a dosing interval or dosage form since these may change, use common medical abbreviations or coined abbreviations, or include or suggest the composition of the drug product.
The June 5–6 meeting will address the pilot program and developments in the science and practice of proprietary name analysis since 2003, when the agency held two public meetings on the subject. Also on the agenda will be the strength of evidence for the agency’s approach to reviewing the names of prescription and nonprescription products and best practices in the absence of a gold standard.
Cobalt dismisses generic Precose lawsuit against FDA
WASHINGTON Cobalt has decided voluntarily to dismiss a lawsuit in which it had asked a court to restore its marketing exclusivity for a generic version of Bayer Pharmaceutical’s diabetes drug Precose.
The company said it was dismissing the case against the Food and Drug Administration without prejudice. Cobalt had brought the suit to the U.S. District Court for the District of Columbia on May 8, alleging the agency had unlawfully forfeited the company’s 180-day marketing exclusivity for a generic version of Precose (acarbose).
Cobalt had maintained that it was the first company to file an application on the drug’s ‘769 patent, which has been removed from the Orange Book. However, the FDA informed Cobalt May 7 that it had forfeited its right to generic exclusivity.
Cobalt said in court documents the FDA acknowledged its actions had delayed the company’s ability to market the product, but the agency said Cobalt had forfeited its exclusivity because it failed to obtain final approval and launch within 30 months of its 2005 application submission.
Cobalt asked the court to enjoin the agency from approving all other applications for the drug “until natural expiration of Cobalt’s statutory right to exclusivity for its acarbose application.” It also requested that the FDA stay or withdraw approval for other acarbose applications, including one from Boehringer Ingelheim’s subsidiary Roxane, which the agency approved May 7. Finally, it asked the court to order the FDA to recall any acarbose product made by Roxane on the market.
The court declined to issue a temporary restraining order against Roxane, finding that under the language of the Food, Drug and Cosmetic Act, Cobalt was unlikely to prevail in the case and Roxane would suffer “significant competitive injury,” Zuckerman Spaeder, the law firm representing Roxane, said.
House releases draft of I.T. legislation
WASHINGTON Rep. John Dingell, D-Mich., chair of the House Energy and Commerce Committee, has released a discussion draft of proposed health care information technology legislation.
Provisions of the draft bill, which contains ideas from at least five House bills introduced during the last two congressional sessions, include the following:
Subject business associates directly to the safeguards in the Health Insurance Portability and Accountability Act privacy and security bills and hold business associates directly accountable to the federal government for violations of minimum contract requirements.
Close a HIPAA loophole that permits disclosure of protected health information for “treatment alternatives.” Authors of the legislation believe providers have used the loophole to send marketing materials to patients without their authorization.
Require regional health information organizations and health information exchanges to have business associate contracts under the privacy rule.
Require personal health record vendors who store the records in one place to notify consumers of data breaches.
Codify, or place into law, the Office of the National Coordinator for Health Information Technology. This would make the position permanent.
Establish two federal advisory committees to prioritize and develop technical data standards.
Establish and fund a health information technology resource center.
Establish grant programs to support provider adoption of I.T., support state-based I.T. loans for provider I.T. adoption, and support local and regional health information exchange initiatives. The discussion draft does not specify funding levels.