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:


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3 Responses to FDA/Pharma Legislative Proposals

  1. Vincent S. Venturella, Ph.D., R.Ph. says:

    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.

  2. Recent Pharma Legislation

    Interested in reviewing recently introduced Pharma legislation? Well, I’d suggest that you head over to Eye on FDA, where Mark Senak provides a thorough review ofrecently introduced Pharma legislation….

  3. Adam J. Fein says:

    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.
    Just my $0.02.

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