Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
Sept. 23 — Vermont Gov. Peter Shumlin (D) has written a letter to key U.S. senators asking them not to confirm Robert Califf as the next leader of the Food and Drug Administration.
On Sept. 15, President Barack Obama nominated Califf, who has been deputy FDA commissioner for medical products and tobacco since January, for the agency's top job. Califf was the founding director of the Duke University Clinical Research Institute, the world's largest academic research organization. Califf would replace former FDA commissioner Margaret Hamburg, who left in March after six years on the job.
In a Sept. 22 letter to Sen. Lamar Alexander (R-Tenn.), chairman of the Health, Education, Labor, and Pensions Committee, and HELP Committee ranking member Patty Murray (D-Wash.), Shumlin cited press reports of Califf's ties to the pharmaceutical industry, and said he shouldn't be appointed FDA commissioner.
“To confirm someone to lead the FDA who has extensive ties to an industry that has repeatedly shown an ability to pull the strings of the regulatory process to get its way is unacceptable,’’ Shumlin said.
“The FDA's history is riddled with examples of a too-cozy relationship with the industry it regulates,’’ Shumlin said. It would be “reckless’’ to appoint someone with close industry ties, he said.
It “sends the exact wrong signal to an American public that has already lost faith in the FDA's ability to prioritize public health over the pharmaceutical industry's profits,’’ Shumlin said in the letter.
Shumlin has been vocal about his state's problem of heroin and opioid drug addiction. He also has been an outspoken critic of a number of the FDA's approvals of pain drugs, including the extended release hydrocodone drug, Zohydro ER (hydrocodone bitartrate extended-release capsules). Zohydro ER is too vulnerable to abuse, Shumlin has said. Shumlin and four other New England governors asked the FDA in August 2014 to overturn its approval of Zohydro ER.
In his Sept. 22 letter, Shumlin criticizes the agency's Aug. 13 approval of OxyContin (Oxycodone) for use in children 11 to 16 years old.
“Expanding the availability of OxyContin at a time when states like Vermont are working so hard to combat the rising tide of opiate and heroin addiction across this country is an unwise policy,” Shumlin said. The FDA arrived at its decision to approve by relying too heavily on reports produced by the drugmaker, Purdue Pharma LP, Shumlin said.
“Asking a company that will benefit from the approval of a drug to evaluate its safety is beyond belief,’’ Shumlin said.
A spokesman in Alexander's office declined to tell Bloomberg BNA during a phone interview if the senator had received other letters and calls about Califf's confirmation. Murray's office didn't respond to a request for an interview.
To contact the reporter on this story: Adrianne Appel in Boston at email@example.com
To contact the editor responsible for this story: Brian Broderick at firstname.lastname@example.org
Shumlin's Sept. 22 letter is at http://src.bna.com/mt.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)