You wouldn't think of "corruption" in any form when you think of the Food and Drug Administration (FDA). Certainly, you wouldn't think of conspiracy and intent to conceal detrimental information to the public. Certainly, you'd be wrong. Those employed by the #Government have the responsibility and duty to "protect" the public. They are supposed to be in the care and custody of information and decisions that may endanger or save lives via regulations. They're not doing a very good job of it.

Racketeering and corrupt organizations

Margaret Hamburg, former FDA Commissioner (May 2009 to March 2015) is facing charges under the "Racketeer Influenced and Corrupt Organizations" (RICO) act for concealing deadly consequences of the drug Levaquin made by Johnson & Johnson. Along with her abuse of power, her husband Peter Brown was a hedge-fund manager at Renaissance Technologies and is also facing RICO charges along with drug giant, Johnson & Johnson. According to the Alliance for Human Research Protection (AHRP) report, Brown's reported income was "$10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012"  due in whole or in part to Defendants’ racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin."

Corruption by design or default

While Hamburg was acting Commissioner, she was instrumental in forming e-cigarette regulations before she left the FDA. Her replacement, Dr. Robert Califf also has financial ties to pharmaceutical giants AstraZeneca, Johnson & Johnson, GlaxoSmithKline and more. While he was the director of the Duke Translational Medicine Institute (DTMI) he received a consulting payment from Johnson & Johnson of $87,500. Taking over where Hamburg left off, Califf released the FDA e-cigarette regulations, and litigation is already pending on the rule. Regulations, by design or default, may be heavily strewn with conflict of interest. With the makers of nicotine reduction therapies and drugs like Johnson & Johnson having an FDA Commissioner and former commissioners ear, corruption may be inevitable.

Are decisions based on health?

Senator Ron Johnson (R-Wis.) wants answers from the FDA about regulations. In a letter, the chairman of the Senate Homeland Security and Governmental Affairs Committee asked Commissioner Califf a few specific questions. Burdensome expenses related to the application and approval costs and public health were of importance in his letter. As he stated, "the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences." Another observation made by Senator Johnson stated:

"The final rule notes that the FDA does “not currently have sufficient data about e-cigarettes and similar products to fully determine what effects they have on the public health."

Then Senator Johnson asked, in part:

"How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have “sufficient data” about e-cigarettes to determine the effects on the public’s health"?

The Committee on Homeland Security and Governmental Affairs is authorized to investigate “the efficiency and economy of operations of all branches of the Government.”  Senator Johnson stated he wanted all material "no later than 5:00 p.m. on May 31, 2016."

#Policy #Crime