FDA & Pharmaceutical Legislative Proposals

by Mark S. Senak
EyeOnFDA.com

My apologies for a late posting today and no posting yesterday. A virus found me.

Well, our friends in Congress (those not running for President) have been busy introducing new legislation. For the sharp-eyed and perceptive among you who do not receive this posting by email, you will notice in the blog's column to the right, the number of legislative proposals that have been introduced has lengthened considerably. It is an effort to keep up! Some of what you will see will look familiar from the 109th Congress.

Here is a recap:

S. 484 - Drug Safety and Oversight (Kennedy-Enzi) - FDA reform that would provide the FDA with greater authority in pre and post-marketing enforcement, among other things.

S.438 - Fair Prescription Drug Competition Act - Introduced by Senator Rockefeller, this would prohibit companies from making generics of their own drugs.

H.R. 3 - Stem Cell Research Enhancement Act - Identical to S. 5 of the same name, this passed the House and would authorize expanded federal funding for stem cell research.

H.R. 331 - Drug Expiration Date Study - This bill would direct the Secretary of Veteran's Affairs to conduct a study on the expiration date of prescription drugs to determine accuracy.

H.R. 380 - Pharmaceutical Market Access and Drug Safety Act of 2007 - This is a big one - allowing for the importation of drugs into the United States in an effort to offer less expensive drugs to consumers. This bill is identical to S. 242.

H.R. 4 - Medicare Prescription Drug Price Negotiation Act of 2007 - The title says it all - would require the Secretary to negotiate prices for drugs under the Medicare Part D program. This has passed in the House as one of the 100 hours effort.

H.R. 63 - RU-486 Suspension and Review Act of 2007 - Again, title says it all.

H.R. 780 - Counterfeit Drug Prevention Act of 2007 - Expands on the penalties for counterfeiting drugs.

S. 137 - Preserving Medicare for All Act 0f 2007 - Senator Cardin takes a broad swing at a number of Medicare issues, encompassing minimizing cost containment while ensuring negotiation by the Secretary on drug pricing.

S. 28 - Generics First Act of 2007 - Would require the use of generics first as part of Medicare Part D.

S. 414 - Cloned Food Labeling Act - Guess what? It would require the labeling of food that comes directly or is derived from cloned animals.