Morning Briefing
Summaries of health policy coverage from major news organizations
House Changes To 'Right To Try' Legislation May Bog Down Chances In Senate
The Hill: House Eyes Changes For ‘Right To Try’ Bill
Lawmakers in the House appear likely to make changes to the “right to try” bill on experimental drugs, something supporters worry could make it harder to get the bill to President Trump’s desk. Advocates of the measure — which would let terminally ill patients request access to treatments the Food and Drug Administration (FDA) hasn’t approved — want the House to take up the Senate-passed bill as is. But that’s unlikely, House Energy and Commerce Committee Chairman Greg Walden (R-Ore.) said Monday. (Roubein, 2/8)
Stat: U.S. Attorney Urged To Re-Open Probe Into An Allergan Unit For Alleged Fraud
Nearly eight years ago, an Allergan (AGN) unit paid $150 million to settle criminal charges of illegally marketing three drugs. Now, the U.S. attorney in Boston is being asked to reopen its investigation after newly unsealed documents suggest the company may have deliberately misled federal officials about a key clinical trial for one of the medicines, undermining the basis for the settlements. Specifically, the documents indicate Forest Laboratories obscured crucial information demonstrating the Celexa antidepressant was not effective in children. Instead, using what its medical director acknowledged was “a masterful stroke of euphemism,” the company portrayed the study results as positive in materials that were submitted to the Food and Drug Administration in hopes of winning approval for pediatric use, according to the court documents. (Silverman, 2/8)
And in other pharmaceutical and medical research news —
Stat: He Calls Animal Testing 'Taxpayer-Funded Torture.' The FDA Listened
Now the 39-year-old founder of an animal rights group, [Anthony] Bellotti last month achieved an important victory for opponents of animal testing. He played a key role in pressuring the Food and Drug Administration to shut down a nicotine-addiction study in which four monkeys died, and prompting the appointment of an independent investigator to look into the agency’s animal research program. Emboldened by that success, Bellotti is redoubling fundraising efforts for his fledgling organization, and publicizing more government-backed medical tests that he believes taxpayers oppose. It is, he suggests, a wholly novel approach to animal-rights advocacy, since no one has previously sold this idea as a way to cut government waste. (Tedeschi, 2/8)
