Regulatory
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Facebook and Web Pages – What Pharma and FDA Need to Know

Interesting History at FDA as Alliance for a Stronger FDA Goes to Bat for Bigger Agency Budget

Weekly Roundup – 3/4/10

We creep closer to Spring.

Merck Says FDA Should Approve the “One-Click Rule”

Merck submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools ( find it here ). About 75% of Merck’s comments that specifically address FDA’s questions is devoted to an argument in favor of the “one-click rule” as it applies to space-limited digital product ads.

FDA: Getting tough with everyone

For well too long food manufacturers like POM Wonderful have been trying to con the American public with unsubstantiated claims. In the case of POM pomegranate juice, the agency said that the company’s Web site, which is listed on its bottles, carried misleading claims that the juice could prevent or cure diseases like hypertension, diabetes and cancer.

AstraZeneca Urges FDA to Regulate the Whole and Nothing But the Whole SM Conversation

AstraZeneca (AZ) submitted comments to Docket No.

What’s Cookin’ Good Lookin’? FDA Issues 17 Warning Letters on 22 Products re Labeling

In what may be the first mass mailing of a letter to a manufacturer since the infamous 14 April 2nd Notice of Violation letters sent to pharmaceutical companies regarding paid search, the FDA yesterday notified 17 food manufacturers of 22 label violations on food products

Time for medical device manfufacturers to be held to same standards as pharma

According to the Wall Street Journal: Some 375,000 adults with Type 1 diabetes used pumps in 2007 and there were nearly 17,000 reports of health problems over the three years ended in 2009, according to the regulators. Makers are required to report problems potentially connected with devices to the FDA.

Another Torrent of Comments to FDA Social Media Docket

My guess is that there is a lag time between the time that comments are actually filed and the time that FDA actually posts them to the rather labor-intensive and not always working correctly Regulations.gov site that houses the comments to the docket for the Part 15 meeting on medical product promotion and the internet and social media.

Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media

Pfizer submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here ). The world’s #1 pharmaceutical company stands alone in calling upon the FDA to develop new regulations for the Internet and social media rather than issuing guidance that puts an “interpretative gloss” on existing rules