mlk_man
05-10-2007, 12:07 PM
Mark Twain once quipped that no one is safe when congress is in session. A century later, he might have added that no health freedoms are safe when our lawmakers are busy...doing whatever they do.
Right now there are a number of pending congressional bills that could significantly cut back on our rights to make our own health care decisions. The one getting the most attention is S. 1082 - The FDA Revitalization Act, which was renamed Drug Safety and Innovation Act of 2007 just last week. Call it what you like, it could easily end up restricting the availability of dietary supplements.
Meanwhile, another important bill with a much lower profile is sneaking in under the mainstream radar: The Safe Compounding Act of 2007. When I first told you about this bill (in the e-Alert "Access Restricted" 3/21/07), I noted that it should more accurately be named The Restricting Drug Compounding Act.
In its current form, this bill would give the FDA broad control over medicines dispensed by compounding pharmacies and would be a huge blow for women who use compounded bio-identical hormone therapy for safe relief from menopausal symptoms. And I've just found out that another group would also be hit hard by the enactment of this bill: children and adults afflicted with autism.
According to a position statement distributed by the National Autism Association (NAA), many medications that treat conditions associated with autism are not available from drug makers - they have to be formulated by compounding pharmacists.
Here are two chilling quotes from the position statement:
1) "The draft legislation outlaws many of these critical medications, and gives the FDA the authority to further eliminate these medications."
2) "According to Congressional Quarterly, pharmaceutical manufacturers are in 'high lobbying mode' in support of the SDCA. Why? Even though compounded medicines, by definition, are distinct from manufactured products, pharmaceutical manufacturers still perceive compounded medicines as competition. And the FDA appears to be driven largely by manufacturers in its regulatory focus."
And just how threatening is this competition? According to the National Association of Boards of Pharmacy, compounded prescriptions accounted for an estimated 1-5 percent of all prescriptions in 2005. That small sliver of the total drug market is apparently just enough to make the insatiable drug giants cranky.
You can read the entire NAA position statement on their web site: nationalautismassociation.org (http://nationalautismassociation.org/). And you can find further information about compounding pharmacists and the Safe Drug Compounding Act (including information about how to contact your congressmen) at the web site for the International Academy of Compounding Pharmacists: iacprx.org (http://iacprx.org/).
To Your Good Health,
Jenny Thompson
Right now there are a number of pending congressional bills that could significantly cut back on our rights to make our own health care decisions. The one getting the most attention is S. 1082 - The FDA Revitalization Act, which was renamed Drug Safety and Innovation Act of 2007 just last week. Call it what you like, it could easily end up restricting the availability of dietary supplements.
Meanwhile, another important bill with a much lower profile is sneaking in under the mainstream radar: The Safe Compounding Act of 2007. When I first told you about this bill (in the e-Alert "Access Restricted" 3/21/07), I noted that it should more accurately be named The Restricting Drug Compounding Act.
In its current form, this bill would give the FDA broad control over medicines dispensed by compounding pharmacies and would be a huge blow for women who use compounded bio-identical hormone therapy for safe relief from menopausal symptoms. And I've just found out that another group would also be hit hard by the enactment of this bill: children and adults afflicted with autism.
According to a position statement distributed by the National Autism Association (NAA), many medications that treat conditions associated with autism are not available from drug makers - they have to be formulated by compounding pharmacists.
Here are two chilling quotes from the position statement:
1) "The draft legislation outlaws many of these critical medications, and gives the FDA the authority to further eliminate these medications."
2) "According to Congressional Quarterly, pharmaceutical manufacturers are in 'high lobbying mode' in support of the SDCA. Why? Even though compounded medicines, by definition, are distinct from manufactured products, pharmaceutical manufacturers still perceive compounded medicines as competition. And the FDA appears to be driven largely by manufacturers in its regulatory focus."
And just how threatening is this competition? According to the National Association of Boards of Pharmacy, compounded prescriptions accounted for an estimated 1-5 percent of all prescriptions in 2005. That small sliver of the total drug market is apparently just enough to make the insatiable drug giants cranky.
You can read the entire NAA position statement on their web site: nationalautismassociation.org (http://nationalautismassociation.org/). And you can find further information about compounding pharmacists and the Safe Drug Compounding Act (including information about how to contact your congressmen) at the web site for the International Academy of Compounding Pharmacists: iacprx.org (http://iacprx.org/).
To Your Good Health,
Jenny Thompson