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Presidential Transition Brief
– Greg Walden (R-OR) will be the next chair of the House Energy and Commerce Committee. Rep. Fred Upton (R-MI), the current chair, stepped down due to term limits.
– President-elect Donald Trump is considering Rep. Andy Harris (R-MD), a former anesthesiologist, to head the National Institutes of Health.
Mylan executives decline invitation to Senate hearing
Sen. Chuck Grassley (R-IA), chair of the Senate Judiciary Committee, scheduled a hearing for Wednesday, November 30 to discuss the Mylan Pharmaceuticals settlement related to the company overcharging the Centers for Medicare and Medicaid (CMS) for the EpiPen. Mylan executives declined the invitation to the hearing, as Department of Justice and CMS executives would not be attending and the focus of the hearing is still pending. Ed Silverman of STAT News explains Mylan’s CEO has accepted an invitation to speak at the Forbes Health Summit on Thursday, December 1 on the same topic.
Mylan CEO speaks at conference, offers no apology
Mylan Pharmaceuticals CEO Heather Bresch spoke about the controversy surrounding EpiPen price increases at the Forbes Healthcare Summit on December 1 in New York City. Justifying the price increases, Bresch asserted the company made improvements to the product’s ease of use, which Mylan considers an advancement. Bresch acknowledged Mylan is responsible for the price increases but did not offer an apology or admit wrongdoing. She also addressed claims the company blamed pharmaceutical benefit managers, clarifying Mylan was trying to draw attention to the need for greater transparency to understand how drugs are priced. Arlene Weintraub of Forbes notes Bresch believes drug costs should reflect consumer expectations but does not feel Mylan should be the only company expected to lower its prices.
Prescription drugs and the Trump administration
Allergan Pharmaceuticals CEO Brent Saunders has penned an op-ed to caution the pharmaceutical industry against complacency. While drug pricing does not appear to be on the top of President-elect Donald Trump’s agenda, Saunders asserts the issue is still relevant as consumers’ displeasure with drug prices continues. Critics have called for increased government regulation of price increases, and Saunders believes pharmaceutical companies need to change their practices before significant regulations are put in place. Saunders has announced Allergan is adding 40 drugs to its list of those covered by its patient assistance program as a complement to the social contract with consumers. Carly Helfand of FiercePharma reports.
FDA advances street drug to final clinical trial
The Food and Drug Administration (FDA) has advanced the common street drug MDMA, also known as Ecstasy, to a phase-three clinical trial, the final step before prescription approval. Researchers are testing MDMA for use in patients diagnosed with post-traumatic stress disorder. Phase two testing has shown the drug decreases the severity of symptoms and eliminates the condition in some patients. Early success has encouraged researchers to apply for breakthrough therapy status, which would make MDMA available as a prescription by 2021. Dave Philipps of The New York Times shares critics caution the drug will still be available illegally and may encourage abuse similar to that experienced with opioids.
Synthetic opioid banned by DEA
The Drug Enforcement Administration (DEA) has added another synthetic opioid, furanyl fentanyl, to its list of banned controlled substances. As the opioid epidemic continues, the DEA has noticed an increase in deaths related to use of illicit synthetic opioids. According to NMS Labs, a private company working with states to monitor opioid issues, more than 300 deaths have been linked to furanyl fentanyl between January and October 2016. Jon Kamp of The Wall Street Journal has the story (subscriber’s content).
Earlier this week:
House passes Cures Act
On Wednesday the House overwhelmingly voted in favor of the 21st Century Cures Act, which increases funding for the National Institutes of Health, aims to improve mental health systems and changes the regulatory process for medical devices and drugs. Critics have expressed concern the legislation will lower Food and Drug Administration standards for approval of drugs and devices. According to Jennifer Steinhauer and Sabrina Tavernise of The New York Times, the bill is likely to pass in the Senate next week.