OverTheCounterToday

“Complex Nature” Of Acetaminophen On NDAC’s Agenda

FDA’s Nonprescription Drug Advisory Committee and two other advisory panels will meet in June to discuss risk management solutions and other possible responses to the public health problem of liver injuries linked to the use of acetaminophen in both OTC and prescription products.
The Drug Safety and Risk Management and the Anesthetic and Life Support Drugs advisory committees will join the NDAC in the meeting June 29-30 in Adelphi, Md., a Washington suburb.
In a notice prepared for the April 24 Federal Register, FDA said a Center for Drug Evaluation and Research multidisciplinary working group appointed in 2007 is expected to issue a report May 22 recommending additional steps the agency could take to decrease the number of acetaminophen-related liver injuries.
FDA said “given the complex nature of the underlying problem of acetaminophen liver toxicity,” CDER Director Janet Woodcock and the working group agreed that the options identified in the report should be presented for public discussion prior to taking further action.
According to the notice, in its deliberations the working group considered detailed reviews from the Office of Nonprescription Products, the Office of Surveillance and Epidemiology and the Division of Anesthesia and Analgesic and Rheumatology Drug Products.

Who Says You're Only Approved Once?

FDA has approved the emergency contraceptive Plan B (levonorgestrel) for OTC sale to 17-year-olds, to comply with part of a recent court ruling that found the decision to attach an age restriction in the first place was "arbitrary and capricious" and poltically motivated. The agency says April 22 the manufacturer may make the appropriate label changes following the submission and approval of an application. The drug currently is sold behind pharmacy counters to women over 17 without a prescription, with a prescription required for women 17 and under.

FDA's decision to comply with the decision and not appeal is hardly unexpected, but it means the saga of Plan B will continue to unfold. A spokesman for the agency said no part of the ruling would be appealed, meaning FDA additionally intends to re-review the whole application -- as ordered -- reconsidering unrestricted OTC sale.

Kansas Gov. Kathleen Sebelius, the secretary-designate of the Department of Health and Human Services, recently said she intends to let doctors and scientists make the call on Plan B’s availability, as the court ruling requests. 
 
OverTheCounterToday blogged about the Plan B ruling here.

The Tan Sheet recently wrote about a number of implications of the court ruling decision here and here.

See national media reports on FDA's announcement here and here.

P&G Races To Stay Ahead Of OTC PPI Competition

If Prilosec OTC’s days of dominating the heartburn relief market are numbered, Procter & Gamble refuses to go quietly into the night. In a citizen petition submitted April 9, P&G calls on FDA to create class labeling that it says would ensure no OTC proton pump inhibitor uses claims that give consumers unrealistic expectations of efficacy and safety. The petition says Novartis’ Prevacid and Santarus’/Schering-Plough’s Zegerid – both believed to be under consideration for an Rx-to-OTC switch – lack data to support “time to full effect” label statements claiming superior efficacy over Prilosec OTC (omeprazole). Further, FDA should require some serious clinical data from either sponsor before allowing claims beyond Prilosec OTC's, the petition says.

FDA Nine Seek Ouster of Potentially Biased Plan B Decision-Makers

A group of FDA scientists is calling for the removal of agency leaders who are suspected of politically motivated decisions regarding the emergency contraceptive Plan B.

In an April 2 letter to President Obama, the nine agency scientists accuse leaders at the Center for Drug Evaluation and Research of caving to political pressure in their handling of Barr Labs’ application to switch Plan B to over-the-counter status.

Sen. Charles Grassley entered the letter into the congressional record during a same-day Senate Finance Committee confirmation hearing for Kansas Gov. Kathleen Sebelius as Department of Health and Human Services secretary.

Grassley also offered a second letter the unidentified scientists addressed to him, which urged the Iowa Republican and ranking member of Finance to “bring these matters to the direct attention” of Sebelius.

Dropping the Hammer on Bolt-ons

Church & Dwight CEO James Craigie offers some perspective on acquisitions that's as straightforward and blunt as the firm's Arm & Hammer logo, in this great piece from our colleagues at the InVivo Blog. Enjoy.