WASHINGTON (Reuters) - U.S. health officials for the first time have proposed withdrawing approval of a prescription drug for the manufacturer’s failure to complete required studies after the medicine reached the market.
British drugmaker Shire Plc did not conduct clinical trials to verify the suggested benefits of hypotension drug ProAmatine, the Food and Drug Administration said on Monday. The drug won approval 14 years ago and is not a big seller for Shire.
If the FDA withdraws the medicine’s approval, generic companies including Mylan Pharmaceuticals Inc, Impax Laboratories and Novartis unit Sandoz must stop selling their copycat versions, the agency said.
Shire has 15 days to request a hearing to object. Officials at the company could not immediately be reached for comment.
The FDA cleared ProAmatine in 1996 for treating orthostatic hypotension, a type of low blood pressure that makes people feel dizzy or faint when they stand up.
ProAmatine won approval under a shorter process used to bring medicines for serious conditions to patients quickly. Drugs cleared that way must pass follow-up tests to confirm earlier findings.
In pre-approval studies, ProAmatine increased standing systolic blood pressure for one minute. As a condition of approval, the FDA ordered Shire to show the drug improved patient symptoms.
“To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit,” the FDA said in a written statement.
Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group, said the FDA action was “commendable but regrettably late,” coming 14 years after the drug’s approval.
The FDA has had the power for years to revoke approval of medicines if required follow-up data was missing. Critics complain drugmakers often go years without completing the studies, with little recourse from the agency.
The Government Accountability Office, the watchdog arm of Congress, criticized the FDA in September 2009 for a “passive approach” to enforcement of confirmatory study requirements. The GAO cited ProAmatine as one example of a drug that lingered on the market despite a lack of proven benefit.
About 100,000 U.S. patients filled prescriptions for brand or generic forms of ProAmatine in 2009, the FDA said. The drug’s generic name is midodrine.
Needham & Co analyst Alan Carr said the FDA action could help Chelsea Therapeutics, a company developing a new drug called Droxidopa for orthostatic hypotension.
“The potential removal of midodrine may create a greater market opportunity for Droxidopa in the U.S.,” Carr said in a research note. The company is due to release new study results on the drug this fall, he said.
The FDA said patients should not stop taking the drug and should consult a doctor about other options.
Reporting by Lisa Richwine; Editing by Steve Orlofsky; editing by Carol Bishopric