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New HHS Secretary portends significant changes at FDA

By Jonathan W. Emord, Esq

(Editor’s note: A constitutional and administrative law attorney, Jonathan W. Emord graduated with a BA in Political Science and History from the University of Illinois in1982 as an Edmund J. James Scholar and a 1985 graduate JD of DePaul University. He served as an attorney in the Federal Communications Commission during the administration of President Ronald Reagan and served as vice president of the Cato Institute.

Emord has litigated before federal courts and agencies for the past 23 years. He has defeated the Food and Drug Administration (FDA) a remarkable six times in federal court.

In his newly released book, “The Rise of tyranny” (Sentinel Press), Jonathan W. Emord explained how the FDA became controlled by the pharmaceutical industry. According to Emord, that control has led to widespread corruption, abuse of power and the approval of a number of deadly drugs in America.)

President Elect Barak Obama’s choice for HHS Secretary, former Senate Majority Leader Tom Daschle, has sent chills up the spines of drug industry executives who have enjoyed years of effective decisional control at the Food and Drug Administration.

Daschle was a key sponsor of legislation to create an Office of Alternative Medicine at the National Institutes of Health, backed a White House policy initiative to explore complementary and alternative medicine, and was a primary Senate sponsor of the Access to Medical Treatment Act. 

Had it been approved, the Access to Medical Treatment Act (AMTA) would have allowed patients who elected a treatment not approved by the FDA to obtain it upon being given fully informed consent. The bill suggests that Daschle is no patsy for big pharmaceutical companies.

A noted advocate of health freedom, author of AMTA and close friend of Daschle’s, former Iowa Congressman Berkley Bedell has been advising Daschle for years about FDA’s actions that sacrifice the interests of patients in accessing experimental drugs and that censor health information.

In his position as HHS Secretary, Daschle will be able to make major changes at FDA if he wants to - and if Obama grants him the authority to do so. He might begin by obtaining the resignation of the present FDA Commissioner Andrew Von Eschenbach. 

Von Eschenbach has come under intense criticism for allegedly serving as a drug industry patsy and for effectively silencing scientists at the agency who called into question the safety of drugs under review. The subject of a rocky confirmation hearing, Von Eschenbach has since been excoriated repeatedly by powerful members on both sides of the aisle, including Charles Grassley (R-IA) and former Senator, now Secretary of State to be, Hillary Rodham Clinton (D-NY). Although Von Eschenbach weathered the congressional storms under the protective cover of the Bush White House, several of his chief critics will now control his political fate. He may well resign before the new administration takes office.

If given the leeway, Daschle will likely favor measures to provide greater public access to unapproved drugs and medical devices that hold promise. He may advocate measures to permit prescription drugs sold at prices lower than those in the American market to be imported and resold here, undercutting those inflated domestic prices. 

Although little is known about his opinion of FDA’s prior restraint on the communication of nutrient-disease information, Daschle may be far more amenable to ending that regime of censorship than continuing it. Consumers will benefit from greater access to health information about the role of foods and nutrients within them and disease.

In “The Rise of Tyranny,” I document corruption in the FDA, explaining that the agency has repeatedly approved drugs that its own medical reviewers have deemed too unsafe to enter the market. Vioxx is but one of dozens of similar examples. 

As the Associate Director of FDA’s Office of Drug Safety David J. Graham has stated, FDA does the bidding of the drug industry, views the industry as its client and repeatedly permits unsafe drugs to enter the market. Graham testified before the Senate Finance Committee that FDA’s actions leave the American public “virtually defenseless” against unsafe drugs. It may be that the days of undue drug company influence over FDA are numbered.

Daschle likely has the inclination to change the dynamic at FDA.  If given encouragement from the Obama administration, he could do much to stem the undue influence of drug companies at the agency, to open the market to promising new drugs, devices, and therapies and to help end censorship of vital nutrient-disease.