FDA clarifies position on low blood pressure drug
PHILADELPHIA The Food and Drug Administration did not completely withdraw from the market a drug used to treat a dangerous low blood pressure condition, but merely proposed to do so as a “step in the regulatory process,” according to a document posted on the agency’s website Monday.
The agency said its proposal last month to withdraw approval for Shire’s drug ProAmatine (midodrine) did not represent the actual withdrawal of the drug from the market, while calling for more data on the drug to verify its clinical benefit.
The drug, originally made by Roberts Pharmaceutical, received accelerated approval in 1996 as a treatment for orthostatic hypotension, a condition in which patients are unable to maintain blood pressure when standing. The drug since has been approved in generic form as well. Shire acquired rights to the drug when it acquired Roberts in 1999.
On Aug. 16, the FDA proposed withdrawing marketing approval for ProAmatine because of a failure of clinical study data to demonstrate its efficacy in patients with the condition, though many patients, physicians and professional groups continue to regard it as efficacious, according to the document. Shire announced Aug. 17 that it had elected to withdraw the drug, effective Sept. 30.
Shire hailed the news. “Shire is very pleased that FDA has stated that ‘continued patient access to midodrine is a key agency priority’ and that the FDA has taken action allowing midodrine to remain accessible to patients and their families who rely on this medicine,” Shire SVP research and development Jeffrey Jonas said. “We look forward to continuing our ongoing discussions with the FDA related to the efficacy of this medicine.”
Pittsburgh Business Group on Health’s LivingMyLife program to expand
PITTSBURGH The Pittsburgh Business Group on Health’s LivingMyLife program, which helps diabetes patients with disease management through the use of “coach pharmacists,” will soon do the same for those with other diseases, according to published reports.
The Pittsburgh Tribune-Review reported Friday that LivingMyLife also would help patients with asthma and heart disease. The program, which began in 2006, allows patients to manage their disease with visits to pharmacies, mostly Giant Eagle, Kmart and some independents.
The announcement was made at the annual healthcare symposium of the group and involved more than 100 attendees, the newspaper reported.
Appeals court upholds decision to OK ‘pay-for-delay’ deals
NEW YORK The federal government got a kick in the face Thursday as an appeals court ruled in favor of patent litigation settlements between branded and generic drug companies.
The U.S. Second Circuit Court of Appeals in New York decided not to reconsider a ruling it made earlier this year in the case of Arkansas Carpenters Health and Welfare Fund vs. Bayer AG. The case concerned the legality of a settlement between Bayer and Teva Pharmaceutical Industries subsidiary Barr Labs over the anthrax treatment Cipro (ciprofloxacin), but the court ruled that the deal between the two companies did not violate antitrust laws.
The appeals court’s decision is a major setback for the efforts of the Federal Trade Commission and members of Congress who have sought to ban such settlements.
In most cases, a generic drug company that wishes to market its version of a drug before the branded drug company’s patents expire will file an approval application with the Food and Drug Administration with a paragraph IV certification, a legal assertion that the patents covering the branded drug are invalid, unenforceable or won’t be infringed by the generic drug. In response, the branded drug company usually will sue, but cases frequently result in settlements whereby the generic drug company agrees to hold off launching its drug in exchange for payment of some sort by the branded drug company.
This often comes in the form of an agreement not to use an authorized generic, essentially the branded drug marketed under its generic name, to compete with the generic drug company during its customary six-month market exclusivity period. Legally, the generic company must launch before the patents expire or as soon as they do, and delaying launch after patent expiry would be illegal, though critics such as the FTC and The New York Times’ editorial board have often derided the settlements as “pay-for-delay” deals, with the FTC contending that they cost consumers billions of dollars a year. Nevertheless, most cases that are settled result in launch of the generic drug ahead of patent expiry. In the case of Bayer and Barr, Bayer paid Barr $400 million to hold off launching its version of Cipro.
“Patents, issued by the government, are given the presumption of validity,” read a statement from the Generic Pharmaceutical Association, the generic drug industry’s main lobby. “Any market entry of a generic drug before the brand patent expires –– whether as the result of a finding that the generic product does not infringe the patent, that the patent is not enforceable or through a patent settlement agreement with the brand company –– is a positive, cost-saving event for consumers.”