Regulatory News - Pharmaceutical Executive


Regulatory News
New developments and strategies for success in dealing with FDA, OIG, SEC, EMEA, and more.

Pharma Companies Hit With Warnings for Search Marketing

April 8, 2009

FDA is cracking down on content in search engine advertisements. The argument is that there is a serious deficiency of risk information in the tiny link ads that appear on search ads. With pharma already wary of marketing online, will FDA’s tactic hurt future Web campaigns?

FDA Demands Pharma Firms Pull Unapproved Drugs

April 1, 2009

The Feds are on the warpath, cracking down on pharmaceutical companies that manufacture and market unapproved prescription narcotics.

Massachusetts Passes New Sales and Marketing Rules

March 18, 2009

The latest state-level attempt to regulate pharma marketing is also the most stringent, requiring both drug and device manufacturers to track and disclose marketing spend. And the state's very important biotech industry is crying foul.

GSK Garners FDA Warning Letter for Extraterrestrial Ad Campaign

March 4, 2009

GlaxoSmithKline received a warning letter for use of misleading imagery in its television ad for Avodart. The Feds felt that comparing prostate size to planets might not be a good idea.

Wyeth Loses Preemption Battle

March 4, 2009

The Supreme Court ruled in favor of the plaintiff in a case that has had the pharmaceutical industry on pins and needles. The verdict hammered home the fact that even though FDA approves a drug, pharmaceutical companies are responsible for making labels as clear as possible.

EMEA/Canada Health Suspend Raptiva Sales

February 25, 2009

After more reports surface that link Raptiva to a deadly brain infection, world drug regulation agencies decide the risks outweigh benefits.

Lilly Gets Green Light to Sell Prasugrel in Europe

February 25, 2009

Lilly's blood thinner earns approval in Europe and challenges Plavix's status as king of the ACS market.

Bayer to Run Corrective Ad for Birth-Control Pill

February 18, 2009

FDA reprimanded Bayer for running misleading advertising touting unproven benefits of the contraceptive Yaz. Now the drug company will shell out $20 million for new ads setting the record straight.

FDA Wants More Gardasil Data

January 14, 2009

One week after submitting data to get Gardasil approved for men, Merck gets a total response letter from FDA requesting additional data before it makes a decision on authorizing the drug for older women.


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