Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

Feds Push to Withdraw ProAmatine

By Drug Discovery Trends Editor | August 17, 2010

WASHINGTON (AP) – Federal health regulators are pushing to withdraw a blood pressure drug that has been on the market for 14 years in spite of the manufacturer’s failure to submit evidence that it actually helps patients.

The Food and Drug Administration approved Shire Laboratories’ drug ProAmatine in 1996 based on promising early results in treating low blood pressure. But the company has never conducted a mandatory follow-up study to actually prove the long-term benefits of the drug.

In letter to the company posted online Monday, the FDA proposes withdrawing the drug from the market and gives Shire an opportunity to schedule a hearing to discuss the matter. The letter marks the first time the FDA has threatened to pull a drug off the market due to missing follow-up data, though it has long held that power.

“This proposal is necessitated by Shire’s failure to conduct postmarketing clinical trials that verify and describe the clinical benefit” of ProAmatine, the agency states.

Calls placed to Dublin, Ireland-based Shire seeking comment were not returned Monday afternoon.

Copies of the letter were also sent to five generic drugmakers who manufacture the drug, including Mylan Pharmaceuticals and Sandoz Inc. Those generic products would also be subject to a market withdrawal, unless their manufacturers complete the study requested by the FDA.

Roughly 100,000 U.S. patients received prescriptions for ProAmatine or generic versions last year, according to the FDA. The drug is approved to treat orthostatic hypotension, a type of low blood pressure that causes patients to become dizzy or faint when standing upright.

The letter does not cite any safety or effectiveness problems with the drug, and suggests the action is primarily aimed at enforcing drug approval regulations that have not always been enforced.

ProAmatine is part of a family of heart drugs that help stimulate dangerously low blood pressure. Several companies sell generic versions of the drug phenylephrine, which is used off-label to treat the condition.

For nearly 20 years, the FDA has granted accelerated approval to drugs based on so-called surrogate endpoints, or initial measures that suggest the drug will make real improvements in patient health. In cancer drugs, for example, tumor shrinkage is considered a predictor of increased survival.

Drugmakers favor the program because it helps them get products to market sooner.

But the program has not escaped criticism from government watchdogs.

Last fall the Government Accountability Office issued a report saying the FDA should do more to track whether drugs approved based on preliminary results actually live up to their promise.

The report singled out ProAmatine as a particularly egregious example of missing follow-up data. The government watchdog said that ProAmatine has generated more than $257 million in sales even though “the clinical benefit of the drug has never been established.”

According to the GAO, the FDA has never once pulled a drug off the market due to missing or unimpressive follow-up data.

The GAO’s September 2009 report found that the FDA had requested 144 follow-up studies for drugs since 1992. Of those about 64 percent had been completed and more than one-third were still pending.

Date: August 16, 2010
Source: Associated Press


Filed Under: Drug Discovery

 

Related Articles Read More >

Takeda Pharmaceutical in the Drug Discovery & Development Pharma 50
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Novartis in the Pharma 50
Novartis to cut up to 8,000 positions
Gilead Sciences in the Drug Discovery & Development Pharma 50
Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir
George Floyd mural
How the pandemic and George Floyd made clinical trial diversity a priority

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50