Friday, March 17, 2006

FDA's little helper

One of the most egregious pieces of legislation to come out of the Bush orifice (I admit this is hyperbole; consider the competition) was Project BioShield (aka Project Bioshill), a catspaw for Big Pharma and biotech predators. Allegedly a mechanism to induce drug companies to aid the common defense against bioterrorism by offering contracts, incentives and giveaways, its first contract went to a little-known biotech company, VaxGen, already on the ropes because its only product, an AIDS vaccine, had failed.

And quite a contract, too. $877.5 million for an anthrax vaccine VaxGen didn't have the expertise to develop and for an incredible quantity of 75 million doses. Anthrax isn't a contagious disease and a vaccine isn't used prophylactically in the civilian population. No one could explain why we needed so much.

Bioshield I was an abject failure and spawned Joe Lieberman's enthusiastic sponsorship of Bioshield II, with even bigger giveaways, including wild card patent protections potentially worth billions to a company. If Bioshield I wasn't working, it must be because we hadn't sweetened the pot enough to make the drug companies contribute to the common defense by only guaranteeing them reasonable profits. They are holding out for obscene profits. Why make vaccines when you can make Viagra?

This Bioshield stuff is pretty popular with the Big Pharma and biotech folks, as you can imagine. Here's what David Boyer said in July 2004 when he was Director of Federal Government Relations at The Biotechnology Industry Organization (BIO). BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states.
The Project BioShield Act of 2004 addresses the three core principals articulated in the president's initiative. While BIO believes that the legislation needs to do more to address liability protection, which is critical to enabling broader participation by the biotechnology industry in the efforts to develop and produce products to counter potential biological attacks, BIO supported passage of this legislation as an important first step.

BIO Position:

Overall, BIO supports the goals articulated in the President's Project BioShield initiative, and is committed to contributing to our nation's common defense. We will work with Congress and the Administration to enact Project Bioshield legislation and look forward to finding future opportunities to address the issue of liability protection, as well as other needs and concerns of the industry. [my emphasis] (BIO press release, July 24, 2004)
Boyer now has an even better opportunity to work with Congress and the Administration "to find future opportunities to address the issue of liability protection, as well as other needs and concerns of the industry."
Acting Commissioner of Food and Drugs (FDA) Dr. Andrew C. von Eschenbach today announced the appointment of David W. Boyer as Assistant Commissioner for Legislation.

Boyer will manage FDA's Office of Legislation. In this role, Boyer will oversee the drafting of congressional testimony, respond to congressional inquiries and assist in the development of public health legislation. Boyer will work closely with the Office of the Commissioner, as well as the six FDA Centers. (FDA Announcement, March 15, 2006)