While bigger legislative packages targeting drug pricing and delays to competition are still sitting in both the U.S. House and Senate, the House Energy and Commerce Subcommittee on Health Wednesday sent an individual bill aimed at stopping sham citizen petitions to the full committee. The STOP GAMES Act, H.R. 2387, has bipartisan support, but a few Republicans on the subcommittee were concerned about wording that would allow the FDA to summarily dismiss petitions that raise genuine scientific concerns if delaying generic competition is deemed to be the primary purpose of the petition. Instead of offering an amendment to address their concerns, they extracted a promise from Energy and Commerce Chair Frank Pallone (D-N.J.) to work on the wording before the full committee marks up the bill. In his comments supporting the bill, Pallone noted that most drug manufacturers use the citizen petition process to raise legitimate concerns, but some have abused it to protect their monopoly. For instance, one manufacturer filed 24 repetitive petitions to delay competition, Pallone said. Such games drain FDA resources for generic drug reviews, he added.
In the Senate Wednesday, Minority Leader Charles Schumer (D-N.Y.) blocked a bipartisan standalone bill that would address drug pricing, pushing instead for the Senate to do something larger "allow Medicare to negotiate." He called the Affordable Prescriptions for Patients Act, introduced by Sens. John Cornyn (R-Texas) and Richard Blumenthal (D-Conn.), a good "but not largely effective bill." The legislation would empower the FTC to challenge product hopping and patent thicketing as anticompetitive actions and to bring antitrust suits against drug companies that abuse the patent system. Cornyn had called for unanimous consent for the full Senate to take up and pass the bill. In rejecting that, Schumer said the Senate should instead vote on a much larger, more comprehensive package that would include Medicare negotiation. Cornyn responded that Schumer's action was "nothing more than a big wet kiss for the people who are gaming the patent system." Three Senate committees have approved bipartisan legislation that was expected to be bundled into one large package, but it has yet to be brought before the full Senate and it wouldn't authorize Medicare to negotiate drug prices. Meanwhile, the House has yet to vote on H.R. 3, a Democratic package that includes Medicare negotiations.
The World Health Organization (WHO) launched a pilot program Wednesday to prequalify human insulin as part of its effort to increase diabetes treatment in low- and middle-income countries. The prequalification is expected to boost access by increasing the flow of quality-assured products on the international market, providing countries with greater choice and patients with lower prices, according to WHO. With three manufacturers currently controlling most of the global market for insulin, prices for the drug are a barrier to treatment in most low- and middle-income countries. WHO data collected over the past four years from 24 countries on four continents showed that human insulin was available in 61% of health facilities and analogue insulins in 13%. A month's supply of insulin would cost patients in Accra, Ghana, the equivalent of 5.5 days of pay per month, or 22% of their earnings. "Prequalifying products from additional companies will hopefully help to level the playing field and ensure a steadier supply of quality insulin in all countries," said Mariângela Simão, WHO's assistant director general for medicines and health products. In addition to the prequalification program, WHO said it plans to update diabetes treatment guidelines in the coming year, devise price reduction strategies for insulin analogues, and improve delivery systems and access to diagnostics.
The Institute for Clinical and Economic Review (ICER) finalized adaptations to its value assessment framework for potential cures and other treatments qualifying as high-impact single or short-term therapies (SSTs). The new adaptations, which will be used in ICER reviews of SSTs beginning next year, include specific scenario analyses to test uncertainty regarding the duration of an SST's benefit, the magnitude or quality of the benefit, or the proportion of patients achieving clinical benefit over their lifetime. ICER panels reviewing SSTs also will consider a treatment's additional elements of value, such as its potential to provide patients more choice in treatment, increase access to future treatment that may be approved over patients' lifetime or, if not successful, reduce or preclude the effectiveness of future treatments. In addition, every ICER assessment of an SST, and some non-SSTs, will include hypothetical "shared savings" scenarios that assess the long-term savings a treatment or cure might produce over the lifetime of a patient. The scenarios will be informative, but they won't replace the institute's established approach for determining value-based price benchmarks, ICER said.
The FDA slapped a Mylan NV manufacturing facility in Chodavaram Village, India, with a warning letter over its handling of raw materials and failure to adequately clean equipment and utensils. The facility manufactures valsartan active pharmaceutical ingredient and has been one of the subjects of an ongoing global investigation into nitrosamine impurities in angiotensin II receptor blockers.