To Circumvent Patent Challenges, This Pharma Company Made A Deal With A Native American Tribe
Now that the deal has been made public, other drugmakers are taking interest. In other pharmaceutical news, the struggle to create a Zika vaccine highlights a broader public health problem, the Food and Drug Administration is changing the way it approves orphan drugs, the House has begun work on a bill that would boost the agency's oversight of over-the-counter drugs, and more.
Stat:
Allergan Patent Deal With Mohawk Tribe Prompts Interest From Other Drug Makers
In the wake of a startling deal in which Allergan (AGN) is selling some patents to a Native American tribe, an attorney for the tribe indicated other drug makers have asked about such arrangements. “I can’t provide specific information, but your assumptions are pretty correct” that representatives for other pharmaceutical companies have made inquiries since the deal was announced last Friday, said Chris Evans of the Shore Chan DePumpo law firm, which brought the deal to the tribe. (Silverman, 9/13)
Stat:
Race For A Zika Vaccine Slows, A Setback For Efforts To Head Off Outbreaks
The development of a type of Zika vaccine that authorities had hoped to usher to the market has proven more challenging than some scientists and pharmaceutical companies had expected, people involved in the research have told STAT, posing a setback for efforts to avoid future outbreaks of the disease. Although vaccines typically take years to produce, test, and license, U.S. health officials had voiced confidence that Zika would not be a difficult target, and some predicted that a vaccine could be made and fully tested, ready for Food and Drug Administration assessment, within two to three years. Others predicted a licensed Zika vaccine could be available sometime in 2020. (Branswell, 9/13)
Kaiser Health News:
FDA Moves To Guard Against Abuse Of ‘Orphan Drug’ Program
The Food and Drug Administration is changing the way it approves medicines known as “orphan drugs” after revelations that drugmakers may be abusing a law intended to help patients with rare diseases. In a blog post Tuesday, FDA Commissioner Scott Gottlieb said he wants to ensure financial incentives are granted “in a way that’s consistent with the manner Congress intended” when the Orphan Drug Act was passed in 1983. That legislation gave drugmakers a package of incentives, including tax credits, user fee waivers and seven years of market exclusivity if they developed medicines for rare diseases. (Tribble, 9/13)
Roll Call:
House Begins Work On Over-The-Counter Drug Fees
The House began public deliberations Wednesday on a bill that would boost the Food and Drug Administration’s oversight of over-the-counter drugs in exchange for industry-paid fees. A bipartisan draft bill released earlier this week has support from the FDA and the over-the-counter drug industry. Under the new proposal, drug manufacturers would pay an annual fee for their facilities and an extra fee each time they submit a request to review proposed changes related to their product. (Siddons, 9/13)
Los Angeles Times:
Bill To Shed More Light On Prescription Drug Prices Heads To Gov. Jerry Brown's Desk
Powered by increasing scrutiny of costly prescription drugs, a measure that would require sweeping new disclosure on how medicines are priced cleared its final legislative hurdle Wednesday. The state Senate approved the bill with no debate, belying the fierce behind-the-scenes jockeying that pit pharmaceutical companies against health insurers, labor unions and liberal activists. (Mason, 9/13)
San Jose Mercury News:
California Drug Price Transparency Bill Heads To Gov. Brown
The nation’s most comprehensive legislation aimed at shining a light on prescription drug prices is heading to California Gov. Jerry Brown’s desk. ... It would do so by requiring pharmaceutical companies to notify health insurers and government health plans like Medi-Cal at least 60 days before scheduled prescription drug price hikes that would exceed 16 percent over a two-year period. (Seipel, 9/13)
The Associated Press:
Maryland Prescription Drug Pricing Bill Up For Court Hearing
A Maryland measure that would empower the state’s attorney general to take action to stop pharmaceutical price gouging is scheduled for a hearing in federal court. A motions hearing is set for U.S. District Court in Baltimore on Thursday. (9/14)
The Washington Post:
Martin Shkreli Jailed After Facebook Post About Hillary Clinton
A federal judge on Wednesday revoked the $5 million bail of Martin Shkreli, the infamous former hedge fund manager convicted of defrauding investors, after prosecutors complained that his out-of-court antics posed a danger to the community. (Merle, 9/13)
The Associated Press:
Pharma Bro Martin Shkreli Has Bail Revoked, Heads To Jail
Defense attorneys had argued at a hearing in federal court in Brooklyn that the post by Shkreli, offering a $5,000 bounty to anyone who could grab him one of Clinton’s hairs while she’s on a book tour, was political satire. But U.S. District Judge Kiyo Matsumoto didn’t see the humor, saying the offer could be taken seriously by fellow Clinton detractors. (Hay, 9/13)
