FDA/Pharma Legislative Proposals

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. 

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Comments

[Vincent S. Venturella, Ph.D., R.Ph.]

I should think that S.438 - Fair Prescription Drug Competition Act -would actually be as much of a restraint of trade as that which it is supposedly trying to prevent.
If H.R. 331 - Drug Expiration Date Study passes, who will tell the FDA that it should rescind its policy (during NDA preparation)of allowing only real time stability data in the application and every supplement or annual report thereafter. Someone should tell the legislators that the Industry is giving the FDA only what it wants as far as expiration dating is concerned.
H.R. 4 - Medicare Prescription Drug Price Negotiation Act of 2007 is noteworthy in that none of the negotiated proces would reach the senior population of PartD.
S. 28 - Generics First Act of 2007 --so much for your physicians' best experience on what is best for the patient. Price is never a good barometer of success.

[Adam J. Fein]

I recall my Schoolhouse Rock well enough to know that these are not laws, but the level of bipartisan support and political rhetoric indicate significant misunderstanding of drug distribution channels. IMHO, politicians are endangering public health by opening up diversion channels for criminals.

The importation bills (H.R. 380/S.242) expand the federal government's powers with regard to both individual U.S. states as well as foreign countries. In addition, track-and-trace is necessary but not sufficient for supply chain security. Adding insult to injury is the fact that track-and-trace technology is not nearly as advanced as these bills imply.

See my blog for details.
http://drugchannels.blogspot.com/search/label/Drug%20Counterfeiting

Just my $0.02.

Adam
http://DrugChannels.blogspot.com