By Jim Martin – The Daily Caller

Seniors depend largely on the medical expertise provided to them by their physicians. We have little choice but to trust that they are helping us make good health decisions, and most importantly, putting safety first.

Cornerstone Therapeutics, a North Carolina Drug Manufacturer announced that it will stop selling unapproved drugs by the end of this year.

By Julian Pecquet
The Hill blog
07/27/10 11:06 AM ET

The 60 Plus Association — known as “the conservative alternative to the AARP” — is launching an awareness campaign regarding unapproved drugs in the marketplace.

In an effort to educate seniors, and consumers of all ages, on the risks and dangers associated with unapproved drugs, Jim Martin, chairman of 60 Plus, released an audio news clip today with important information on the issue.  In the clip, Martin urges the FDA to fully enforce its unapproved drugs initiative.

By Kurt R. Karst

Earlier this week, Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction in the U.S. District Court for the District of Wyoming requesting that the court enjoin FDA from taking any enforcement action with respect to their marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL products.  The lawsuit is (to our knowledge) the first challenge arising from FDA’s Unapproved Drugs Initiative, which was kicked off in June 2006 with the publication of the Agency’s Compliance Policy Guide (“CPG”).  FDA’s CPG articulates the Agency’s risk-based enforcement approach to taking enforcement action with respect to the manufacture and distribution of marketed unapproved drugs.  Under that policy, FDA gives higher priority to enforcement action against unapproved drugs in certain categories, including drugs that present direct challenges to the “new drug” approval and over-the-counter drug monograph systems (e.g., when a drug is approved under an NDA and other companies market the same product without approval). (An article we authored that appeared in RAPS Focus a couple of years ago discussing the world of marketed unapproved drugs is available here.)

by Courtney Perkes
The Orange County Register

Federal marshals seized $39,000 worth of unapproved drugs Thursday from a Laguna Hills company, the Food and Drug Administration said.

The Partnership for Public Service recently penned a Washington Post article on an FDA official named Deborah Autor who has played an instrumental role in removing over 500 unapproved drugs from the market.