January 28, 2015—The Republican chairman of the House Energy and Commerce Committee yesterday released the first draft of legislation to spur the development of disease-curing drugs, but the lead Democrat on what is called the 21st Century Cures Initiative declined to endorse the discussion document. [ms-protect-content id=”2799″]
One of the draft bill’s many provisions would grant an unprecedented 15 years of market exclusivity to a new classification of medicines – “dormant therapies” – that treat unmet medical needs. The section is based on legislation introduced in the waning days of the last Congress by Sens. Orrin Hatch (R-Utah) and Michael Bennett (D-Colo.). Another section of the draft bill would reward developers of orphan drugs by providing six additional months of market exclusivity for a drug “if the company establishes that the drug treats a rare disease and receives a rare disease indication from the [Food and Drug Administration] on its label,” according to a section-by-section analysis of the bill. Drug manufacturers are suing the Health Resources and Services Administration over its position that the 340B statute permits rural and cancer hospitals to purchase orphan drugs at 340B prices when the products are used to treat common conditions.
The draft bill also would extend market exclusivity for “American-manufactured generic drugs and biosilimars” by an unspecified period. Another section would extend exclusivity for two years “for significant improvements to existing molecules” such as “new delivery systems, new drug combinations, and new formulations that lead to less adverse events and increase patient benefits and adherence.”
On a different front, the draft bill would require the Centers for Medicare & Medicaid Services “to analyze and seek public input on how proposed Medicare payment policies would affect the consolidation of providers and payers.”
“These ideas represent an important milestone – a critical first step in a legislative process,” Chairman Fred Upton (R-Mich.) said in a statement on the Energy & Commerce Committee’s website. “Some things may be dropped, some items may be added, but everything is on the table as we hope to trigger a thoughtful discussion toward a more polished product.”
Rep. Diana DeGette (D-Colo.), who partnered with him on more than a dozen formal hearings and informal roundtables about the initiative last year, said that “while I don’t endorse the draft document, I know that with continued engagement, we can reach a bipartisan consensus to help advance biomedical research and cures.”
Energy & Commerce Ranking Member Frank Pallone (D-N.J.) said he was disappointed that the draft bill “does not reflect true bipartisan collaboration.”
“Moving forward, I stand ready to work with Chairman Upton, and all Members of the Energy and Commerce Committee, to find bipartisan consensus legislation that would pass the House and the Senate and ultimately be signed by the President,” he said.
Pharmaceutical Research and Manufacturers of America President and CEO John Castellani said PhRMA “supports the Committee’s goal of accelerating the discovery, development and delivery of new medicines for patients” and “look[s] forward to providing feedback.” In a post on Twitter yesterday after the draft bill’s release, Biotechnology Industry Organization said, “We need forward-looking public policies that sustain scientific discovery & biopharma advances to save lives, reduce suffering.”
A few days prior to the draft bill’s release, labor unions and advocates for retirees told Reps. Upton and DeGette in a letter that legislation to spur development of disease-curing drugs should ensure that patients with limited incomes can afford them.
“As you look to enhance access to new treatments, we encourage you to consider how the high costs of prescription drugs can limit the availability of life-saving medications,” AARP, the AFL-CIO, the American Federation of State, County, and Municipal Employees, and eight other groups wrote in their Jan. 21 letter.
“Congress should ensure that measures to extend drug manufacturers’ monopolies and increase the financial burden on taxpayers and government programs are extremely limited,” the letter continued. Expansions of market exclusivity should be extremely limited,” the groups urged. They also recommended authorizing the Secretary of Health and Human Services to negotiate drug prices on behalf of Medicare beneficiaries when an innovative new therapy has no competition, and requiring drug manufacturers to provide rebates on drugs purchased by low-income Medicare Part D beneficiaries.
A number of patient advocacy, drug industry, business, and affiliated groups argued in a Jan. 27 letter to members of Congress that “a mandatory Medicaid-style rebate in Medicare Part D is a poorly informed, ill-conceived policy change that poses serious risks to the health and well-being of millions of seniors and persons with disabilities who rely on this critical program.” [/ms-protect-content]