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The drug, originally made by Roberts Pharmaceutical, received accelerated approval in 1996 as a treatment for orthostatic hypotension, a condition in which patients are unable to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.
DSC debunks industry misconceptions at briefing
WASHINGTON The Congressional Dietary Supplement Caucus, in cooperation with two trade associations representing the dietary supplement industry — the Natural Products Association and the Council for Responsible Nutrition — held a briefing on Capitol Hill Thursday in an effort to debunk some of the untruths and misconceptions about the dietary supplement industry and its role in Americans’ wellness regimens.
“It’s all about prevention. Prevention is the new mantra among consumers,” suggested guest speaker Patrick Rea, publisher and editorial director of Nutrition Business Journal.
Speaking to an audience of staff members from the House of Representatives and Senate, Rea said that even during tough economic times, consumers turn to dietary supplements as an important part of their immunity and prevention plan.
“Consumers looked at supplements as one way through the recession to help take care of themselves. Health is recession resilient, and the sales over time support this fact,” Rea said.
Rea addressed several “industry myths” –– including the notions that dietary supplements are unnecessary because people get what they need from food, that people really do not want to take supplements, that the pharmaceutical industry will destroy the dietary supplement industry and that the industry is unregulated.
“Our numbers show that somewhere between 60% to 80% of Americans take supplements, and 48% of them consider themselves regular users,” Rea said.
Rea also mentioned the growing acceptance of dietary supplements among conventional health practitioners, and the growing trend among pharmaceutical companies to develop their own versions of products usually sold as supplements.
“In a study of healthcare professionals, 72% of physicians and 89% of nurses are dietary supplement consumers, and 79% of physicians and 82% of nurses recommend dietary supplements to their patients,” Rea noted.
Regarding industry regulation, Rea countered that the supplement industry is one of the more highly regulated industries and that the industry welcomes those regulations. “[For example], a lot of the [dietary supplement] companies are rallying behind the [good manufacturing practices] regulations,” he said. “They want it to be known that they are a GMP-compliant company. And, the Dietary Supplement Health Education Act made claims rules clear and has really helped the industry focus and develop.”