Morning Briefing
Summaries of health policy coverage from major news organizations
Democrats' New Bill To Allow Medicare To Negotiate Drug Prices Would Give Government Leverage If Talks Fail
Stat: Democrats Introduce A Bill To Allow Medicare Negotiations And Sidestep Patents If Talks Fail
As the Trump administration labors to execute its blueprint for tackling high drug costs, a group of Democratic lawmakers introduced a bill on Wednesday that would allow the federal government to negotiate on behalf of Medicare — and authorize licenses for lower-cost generics when talks fail. Unlike other bills that would permit negotiations over Part D drugs, the legislation would allow the Department of Health and Human Services to pursue a generic alternative by issuing a competitive license when a company refuses to offer a reasonable price. In effect, the bill would create a new mechanism for the U.S. government to sidestep patents when it would be in the public interest to do so. (Silverman, 7/25)
The Hill: House Dems Introduce Bill To Allow Medicare To Negotiate Drug Prices
Democrats have attacked Trump for not going far enough to reduce soaring medication costs. “This bill calls the President's bluff on his drug pricing promises,” said Rep. Lloyd Doggett (D-Texas), who is a lead sponsor of the bill along with Reps. Peter Welch (D-Vt.) and Elijah Cummings (D-Md.). Doggett said in an interview that lawmakers are introducing the bill now so that it can be fine-tuned and ready for a push next year if Democrats win back the House in November. (Sullivan, 7/25)
Politico Pro: CMS Weighs Competitive Drug Purchasing For Medicare Part B
CMS is considering using its innovation center to test a competitive acquisition program to pay for Medicare Part B drugs. Medicare is seeking public comment on the idea before moving forward with a formal proposal. (Karlin-Smith, 7/25)
Stat: Bill To Eliminate ‘Gag Clauses’ On Drug Prices Advances In Senate
Lawmakers on a key Senate health committee advanced legislation to make it easier for pharmacists to tell consumers if they could pay less for a drug if they don’t use their insurance. It’s a first step for a relatively small bill, but the legislation is one of only a handful of drug pricing bills that has cleared any Senate committees this year, even as policymakers across Capitol Hill say they want to prioritize efforts to bring down the cost of prescription drugs. (Mershon, 7/25)
The Hill: Senate Panel Approves Bill Banning 'Gag Clauses' In Pharmacy Contracts
The clauses prevent a pharmacist from telling a customer if, for example, their $20 co-pay is higher than the pharmacy’s cash price for a drug. The bill, sponsored by Sen. Susan Collins (R-Maine), would ban these clauses. “Many Americans struggle to afford their prescriptions,” Health Committee Chairman Lamar Alexander (R-Tenn.) said. “Senator Collins’ bill ends ‘gag rules’ that prevent a pharmacist from telling a patient that a prescription is cheaper if the patient pays cash instead of using his or her insurance.” (Hellmann, 7/25)
In other pharmaceutical news —
Stat: Trump Administration Proposes More Cuts To Drug Discounts That Aid Hospitals
The Trump administration wants to expand its cuts to a controversial drug discount program that benefits hospitals. Its latest proposal, out Wednesday, centers on the so-called 340B program, which forces drugmakers to give some safety net and not-for-profit hospitals discounts on nearly all their drugs. Federal programs reimburse them for the same medicines at a higher rate, and hospitals say they use the spread to pay for charity care and other services. (Mershon, 7/25)
Stat: New Jersey Looks To Loosen Restrictions On Dinners For Docs, A Victory For Pharma
In a victory for the pharmaceutical industry, New Jersey plans to loosen a new rule that restricts what drug makers can pay for meals for doctors, dentists, nurses, and other prescribers. The rule, which went into effect last January, caps what prescribers can earn from drug makers at $10,000 a year, and limits “modest” meals given to prescribers at just $15. The move was the first state effort to take a comprehensive approach to limiting industry sway and came in response to concerns that some drug makers may use various forms of payments to influence prescribing of opioids. (Silverman, 7/25)
Stat: Did AbbVie Unfairly Thwart Competition By Creating A 'Patent Thicket'?
In a little noticed order, a federal judge recently raised the intriguing possibility that a so-called patent thicket — a large number of patents that a drug maker obtains to thwart rivals — might stifle competition if the patents were established as the result of some misbehavior. The order was issued last month in a lawsuit filed by AbbVie (ABBV), which is seeking to prevent Boehringer Ingelheim from marketing a biosimilar version of its Humira rheumatoid arthritis treatment. The medicine generated nearly $12.4 billion in sales last year in the U.S. alone for AbbVie and is protected by dozens of patents, many of which do not expire until 2022. (Silverman, 7/26)
Stat: Sarepta Halts Early-Stage Gene Therapy Trial For DMD
Sarepta Therapeutics’ clinical trial for a gene therapy to treat Duchenne muscular dystrophy has been paused by the Food and Drug Administration because some of the materials used in the treatment weren’t as they should be, the company announced Wednesday. A stray DNA fragment was found “in connection with routine quality assurance testing” of the plasmids used in the company’s gene therapy, said Douglas Ingram, Sarepta’s president and CEO. Plasmids carry the genetic material used in gene therapy into a cell. The FDA notified Nationwide Children’s Research Institute, where the trial is being conducted, of the clinical hold on Tuesday. (Sheridan, 7/25)
The Washington Post: Federal Appeals Court Won’t Reconsider Rejection Of Md. Drug Price-Gouging Law
A federal appeals court has denied a request from Maryland Attorney General Brian E. Frosh (D) to rehear a lawsuit challenging the state’s drug price-gouging statute. Frosh asked the U.S. Court of Appeals in April to reconsider the case after a three-judge panel of the court ruled that the law violates the commerce clause of the Constitution. The court rejected the request on Tuesday. (Wiggins, 7/25)
