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The drug, originally made by Roberts Pharmaceutical, received accelerated approval in 1996 as a treatment for orthostatic hypotension, a condition in which patients are unable to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.”
The Apothecary Shops earns spot on Inc.’s fastest-growing private companies list
PHOENIX Diplomat Specialty Pharmacy isn’t the only one to earn a spot on Inc. magazine’s list of the fastest-growing private companies.
The Inc. 5000 also listed specialty pharmacy The Apothecary Shops, ranking 2,394. That marked a jump of 322 spots from last year and 1,682 spots from 2008 in its fourth annual appearance on the list.
Drug Store News reported Thursday on Diplomat’s inclusion on the list.
“It’s no secret that we have undertaken a very aggressive growth strategy for The Apothecary Shops, but our approach, particularly in a down economy, has been targeted and strategic to be in a solid position to leverage that growth when the economy turns,” The Apothecary Shops president Keith Cook said. “Our movement on the Inc. 5000 list of fastest-growing companies reflects the success of our strategic direction.”
CMPI survey: Alcohol, marijuana biggest substance problems among teens
NEW YORK The Center for Medicine in the Public Interest on Thursday released the results of a national Teen Substance Abuse survey, indicating that police officers and high school teachers nationwide believe alcohol and marijuana are the most serious problem substances facing teenagers.
The results were released one week prior to a Sept. 14 Food and Drug Administration Advisory Committee meeting called to discuss whether or not additional sales restrictions need to be placed on dextromethorphan, a popular cold remedy ingredient that has been associated with teenage drug abuse. According to the survey, police and teachers polled do not believe it is a good idea to force Americans to visit a doctor to get a prescription to purchase commonly-sold cough-cold medicines.
When asked which substances do pose the greatest negative impact on teens, teachers and police identified marijuana and alcohol, followed by methamphetamine and cocaine. More than 1-in-4 police officers (27%) identified prescription drugs acquired by teens as having the greatest negative impact on teens, as compared with 15% of teachers. Nonprescription medicines were named by 1% of police officers as having the greatest negative impact; 2% of teachers identified over-the-counter medicines as such.
The survey also revealed that by a margin of 2-to-1, police officers and high school teachers support education efforts as a means to address abuse of OTC cough-and-cold medicines, versus restricted accessibility to consumers.
“Americans expect to be able to buy cough medicines conveniently at the supermarket or their neighborhood corner store,” stated CMPI VP Robert Goldberg. “Overly restricting access to cough-and-cold products containing dextromethorphan will create more health problems than it will solve, especially during cold-and-flu seasons. We need to find common sense solutions and invest more resources in education.”