Updated: Governor Takes Issue With Super Bowl Drug Ad as New House Bill Looks to Restrict DTC Pharma Advertising

Posted 16 February 2016 By Zachary Brennan


[Editor's note: This story was updated with new details on the text of the DeLauro bill to restrict DTC pharma advertising and new details on a letter from AstraZeneca to Gov. Shumlin].

Vermont Gov. Peter Shumlin (D) has sent a letter to pharmaceutical companies AstraZeneca and Daiichi Sankyo calling on them to pull their advertisement that aired during the Super Bowl. The ad promoted a drug to treat opioid-induced constipation.

“Like many Americans, I was baffled by the commercial your companies paid an estimated $10 million to air during the Super Bowl. In the midst of America’s opiate and heroin addiction crisis the advertisement was not only poorly timed, it was a shameful attempt to exploit that crisis to boost your companies’ profits,” Shumlin said in the letter.

He also said he’s placing the blame for the US opioid crisis at the feet of the US Food and Drug Administration (FDA) and pharma industry, which he claims “have enabled pain management practices that in 2012 resulted in the issuing of enough opiate prescriptions to give every American their own bottle of pills.”

AstraZeneca has since sent a letter to Gov. Shumlin, explaining how it believes the advertisement "encourages a clinically important conversation about OIC [opioid-induced constipation] between patients and their doctors, which may also facilitate a broader discussion about safe and appropriate opioid use." The company did not say if it would pull the advertisement.

Other Efforts

FDA has recently said it would re-evaluate its opioid policies, with new provisions such as adding more post-marketing requirements and the collection of more data on opioid use. Several House and Senate bills were also introduced to help deal with the opioid crisis and Sen. Joe Manchin (D-WV) late last week introduced a bill that would amend FDA’s mission statement to hold the agency responsible for dealing with opioid abuse and addiction.

Meanwhile, Sen. Ed Markey (D-MA), who, like Manchin, is holding up the nomination of Dr. Robert Califf to be the head of FDA, said in a recent Senate speech that FDA has been “turning its back” on outside expertise on the issue of opioids, particularly as it approved the opioid Zohydro, even after an advisory committee voted against recommending its approval, and did not hold advisory committee hearings before approving two other prescription opioids.

David Juurlink, professor at the University of Toronto School of Medicine, told Focus when the new FDA plan came out: "Practically speaking, I'm not sure this is going to accomplish much of anything at all. I'm in favor of abuse deterrent formulations and Naloxone [an overdose antidote], but these are very small pieces of a very big puzzle."

And as far as the opioid-induced constipation drug commercial, according to the US Pain Foundation, nearly 8 million people who are on opioids suffer from related constipation.

Shumlin, however, called on the companies to pull the advertisement and spend the money on opioid and heroin prevention efforts: “If your profits are such that they allow you to spend millions of dollars for one advertisement, surely you can join everyone from President Obama to those providing addiction treatment services on the front lines in fighting America’s opiate addiction crisis.”

Shumlin did not take issue with another gut drug advertisement from Valeant Pharmaceuticals that also aired during the Super Bowl. Valeant earlier this month came under fire from the House Oversight Committee for raising the prices of several drugs by more than 200% and using a public relations strategy to divert attention away from the price increases. A Senate committee in November also took issue with Valeant’s price hikes.

New House Bill

Late last week, Rep. Rosa DeLauro (D-CT) also introduced a new bill that would amend the Federal Food, Drug and Cosmetic Act to restrict direct-to-consumer (DTC) drug advertising. 

The bill, known as Responsibility in Drug Advertising in 2016, the text of which was released Wednesday, calls to prohibit all DTC ads for the first three years after a new drug is approved.

But as the Congressional Budget Office notes, several attempts in the past to restrict DTC ads have not been adopted by Congress.

Gov. Shumlin Letter

H.R.4565 - To amend the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug advertising.

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Categories: Drugs, Crisis management, Compliance, Government affairs, News, US, FDA, Advertising and Promotion

Tags: Manchin, Markey, opioids, Califf, FDA, Valeant, AstraZeneca, Daiichi Sankyo

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