In this week's roundup...
Procter & Gamble lands sleep-aid OTC rights as it dips toes in Rx waters: The firm says...
OTC recalls prompt rumors of FDA preparing to prosecute: CNNMoney notes...
Nationwide egg recall revives food safety debate: USA Today reports...
Procter & Gamble lands OTC sleep-aid rights as it dips toes in Rx waters: Procter & Gamble dips its toes back into Rx drug waters while also getting OTC rights for Silenor (doxepin) in its agreement with Somaxon Pharmaceuticals to market the drug indicated for insomnia characterized by difficulty with sleep maintenance, the firms said here Aug. 25.
P&G returns to Rx marketing a year after selling its prescription drug business to Warner Chilcott in a $3.1 billion deal, as "The Tan Sheet" reported here. For more on P&G's deal with Somaxon, look on "The Pink Sheet" DAILY, Elsevier Business Intelligence's online source for analysis and insight on pharma business and regulatory developments.
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OTC recalls prompt rumors of FDA preparing to prosecute: Johnson & Johnson's OTC product recalls have some speculating the FDA could be close to dusting off its authority to bring criminal charges against corporate executives.
CNNMoney reports here that a source "familiar with the agency's thinking" says FDA "is serious about identifying and potentially prosecuting senior individuals at companies that have issued a number of recalls due to manufacturing violations."
As "The Tan Sheet" reported here, the "Park Doctrine" gives FDA authority to seek criminal convictions for Food, Drug and Cosmetic Act violations against executives, even if they were unaware of specific manufacturing violations but were in a position to prevent or correct the problems.
We most recently reported here on recalls by J&J's McNeil Consumer Healthcare business, including Chidren's Tylenol products, and the attention the firm is attracting from FDA, Congress and tort lawyers.
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Nationwide egg recall revives food safety debate: Strengthening food safety enforcement already was important to FDA, industry stakeholders and some members of Congress, but the latest nationwide recall of a household staple – eggs – is putting the issue into overdrive, as USA Today reports here.
The recall even has FDA Commissioner Margaret Hamburg working while vacationing. Hamburg Aug. 23 touted the agency's support for stronger food safety enforcement on TV network morning news shows and participated in a conference call with media later in the day. "I'm supposedly on vacation now, but this is very important and I did want to join at least very briefly," the commissioner said during the call, which "Health News Daily" reported on here.
As "The Tan Sheet" reports here, significant differences between the House and Senate food safety bills could threaten the legislation's chances.
(If you're finding gaps in your OTC pharma and nutritional supplement industry news, try the in-depth coverage and analysis offered by "The Tan Sheet." Click here to check out a free issue.)
-- Malcolm Spicer (m.spicer@elsevier.com)
