The House Energy and Commerce Committee on Wednesday released an updated draft of a bill that would overhaul parts of the Food and Drug Administration, adding more details on provisions on drug exclusivity, interoperability and telehealth ahead of a subcommittee markup tomorrow.
The new draft, authored by two Republicans and three Democrats, modifies several proposals that Democrats refused to support in an earlier version first released in January.
“Every policy has been scrutinized, every voice considered,” Rep. Fred Upton (R-Mich.), chairman of the committee, said today in a statement.
The updated legislation almost entirely removes controversial exclusivity provisions that were proposed in January. That language would’ve given brand-name pharmaceutical companies a longer period of exclusive market share before cheaper, generic versions of drugs could be sold. Democrats and interest groups such as the American Association of Retired Persons raised concerns that extending exclusivity could make new drugs unaffordable.
“Longer monopoly patents will block generic competition, limiting access and increasing drug costs,” Rep. Jan Schakowsky (D-Ill.), a member of the panel’s Subcommittee on Health, said last week in an email. “Exclusivity rights are already afforded to many approved drugs to provide incentives for innovation.”
The new draft gives a six-month exclusivity extension to drugs that are repurposed to treat rare diseases. The January text had proposed extending exclusivity rights for sponsors of dormant therapies, defined as drugs that fulfill one or more unmet medical need, to 15 years.
The National Health Council, which represents patient advocacy groups, said it is “extremely disappointed” that exclusivity for dormant therapies was taken out of the new draft.
“We believe the committee has missed a huge opportunity to include a game-changing dormant therapies provision that could have revolutionized the development of treatments desperately needed by people with long-term, life-threatening conditions,” Marc Boutin, National Health Council’s CEO said today in a statement.
The new draft also includes a proposal by Rep. Mike Burgess (R-Texas) that would require electronic health record vendors to abide by new interoperability standards.
The provision would also require the Department of Health and Human Services to partner with a “charter organization” to develop guidelines to evaluate how interoperability is currently included in medical systems. HHS and the organization would then release a report in the summer of 2016 regarding their findings and formulate a path forward to achieve the initiative’s goal.
Electronic health record (EHR) vendors that fail to meet the federal government’s definition of “interoperability”—whether one vendor’s EHR system can work with a different EHR system—by a January 2018 deadline could face decertification, according to the draft text. Systems that are kicked out of the program would be largely useless to doctors and hospitals, who would get penalized by the federal government for not using a system that meets their standards.
Another issue that has been addressed in the new draft is telehealth. The draft measure would require the administrator of Centers of Medicare and Medicaid Services to provide information to Congress regarding the state of telehealth in Medicare, with the goal of using the assessment to develop solutions.
Upton said he wants to move the legislation through Congress by the end of the year.
“We’ve pushed harder and faster than anyone thought possible, because we know patients cannot wait,” Upton said today in his statement.