FDA, Some Senators Voice Concern Over Drug-Patenting Process

FiercePharma: To Lower Drug Prices, Senate Leaders, FDA Urge U.S. Patent And Trademark Office To Alter Patent Processes 
The Senate and the FDA are appealing to the U.S. Patent and Trademark Office (USPTO) to examine how it can limit the ability of pharmaceutical companies to leverage patent strategies to extend their drug monopolies. In separate letters last week to the USPTO, FDA acting Commissioner Janet Woodcock, M.D., and Sens. Patrick Leahy, D-Vermont, and Thom Tillis, R-North Carolina, of the Senate Judiciary Intellectual Property Subcommittee provided (PDF) suggestions on how the organization can better screen patent applications. (Dunleavy, 9/14)

Stat: FDA Commissioner, Two Senators Raise Concerns About Patent Abuse
In a bid to address the high cost of medicines, Food and Drug Administration Commissioner Janet Woodcock wrote the U.S. Patent and Trademark Office to express concern about moves that companies use to extend their monopolies as well as suggestions for curtailing some of these practices. The Sept. 10 letter was sent in response to an executive order issued last June by President Biden to lower prescription drug prices, notably by promoting more competition through greater access to generics and biosimilar medicines. The Biden administration has targeted the rising cost of medicines as a key initiative and various proposals are winding their way through Congress. (Silverman, 9/13)

In related news about drug-pricing reform —

FiercePharma: As Congress Considers Drug Price Reforms, Merck, Lilly And Takeda Execs Warn Of Dire Consequences 
As Congress reconvenes this month to resolve a $3.5 trillion budget package, Democrats are focused on enacting sweeping legislation that would allow the government to negotiate prices for prescription drugs. On Wednesday, Merck’s executive chairman and former CEO Ken Frazier warned of dire consequences from such a move. “The proposals that we’re seeing from Congress will devastate this industry,” Frazier said during a virtual press conference hosted by lobbying organization PhRMA. “While large companies like Merck will survive, we will do significantly less research. ”Under the proposal, Merck would cut its R&D efforts by nearly 50%, Frazier said. (Dunleavy, 9/8)

FiercePharma: Novo Nordisk, Roche See Outsized Threats From U.S. Drug Pricing Talks: Analysts 
While Congress and the U.S. government have sought to lower drug prices for years, the issue appears to be coming to a head once again in Washington, D.C. The proposals that officials are eyeing aren’t new, but they could have outsized effects on some of the industry's largest players. Analyzing the potential effects of drug pricing reform for European big pharma companies including AstraZeneca, Novartis and Sanofi, the team of analysts at ODDO BHF thinks Roche and Novo Nordisk stand to lose the most under the pricing proposals being discussed. (Sagonowsky, 9/13)

Axios: What Hospitals Don't Like About Democrats' Drug Pricing Bill 
Hospitals are worried that the Democrats' plans to curb prescription drug costs could be the beginning of a slippery slope that ultimately cuts into their bottom lines, too. Why it matters: Hospitals and drug companies aren't always allies, and hospitals aren't likely to lobby very hard solely on pharma's behalf. But the industry could become another powerful opponent for Democrats if its own profits are on the line. (Owens, 9/14)

Forbes: Biden Administration’s Prescription Drug Pricing Plan Promotes Incremental Change, Not Overhaul Of System
On Thursday, September 9th, the White House released a long-awaited plan to reduce prescription drug prices and out-of-pocket costs for patients. The plan is more conspicuous for what it doesn’t tackle, or leaves unsaid, than what it addresses (mostly) indirectly and incrementally. The report asserts that prescription drug prices in the U.S. are “too high,” putatively due to lack of competition. The plan identifies myriad “market failures” that prevent competitive pricing of drugs from occurring. According to the report, the prescription drug market exhibits “monopolistic or oligopolistic behavior.” As illustrations, the report cites stakeholders erecting barriers to entry, such as patent thickets and pay-for-delay schemes. Without elaborating, the report points to the market operating suboptimally by incentivizing list price inflation, and encouraging a disproportionate amount of research and development spending to go towards “me-too drugs rather than new treatments and cures.” (Cohen, 9/12)

And in other pharmaceutical news —

Insider: Cancer-Drug Prices Increase In The US, While European Countries Prices Fall Over Time
As the federal government considers a plan to lower the price of some costly drugs, researchers have found that while US cancer-drug prices consistently rise faster than inflation, our European counterparts have seen prices fall. The US spends more than double what other industrialized countries do per capita on prescription drugs, and 79% of Americans agree that the cost of prescription drugs is too high. (Khatib, 9/10)

FiercePharma: Bausch Pays Whopping $300M To Settle Glumetza Pay-For-Delay Lawsuit After 800% Price Hike 
Bausch Health, which industry watchers may remember by its former name Valeant, has been riddled in controversy for years over its defense of diabetes med Glumetza. Now, the company will pay millions to put those charges to rest. Bausch has agreed to dish out $300 million to settle a 2019 lawsuit that claimed the Canadian drugmaker paid off its generic rivals nearly a decade ago, allowing the company to jack up prices for the type 2 diabetes heavyweight by 800% shortly thereafter, according to a Wednesday court filing. (Higgins-Dunn, 9/10)  

FiercePharma: Hims & Hers Drafts Super Bowl Star Rob Gronkowski To Drive Men's Health Awareness 
Notoriously laid-back NFL star Rob Gronkowski is looking to score for the telehealth and medication delivery service Hims & Hers Health with messages on social media, digital, TV and streaming audio. Gronkowski—nicknamed “Gronk” and well-known as a favorite passing target for star quarterback and friend Tom Brady—hits Hims & Hers’ millennial target right in the numbers. Chief Medical Officer Patrick Carroll, M.D., said his own millennial son, who’s a fan of Gronk’s former team, the New England Patriots, excitedly texted him about the news. (Bulik, 9/10)