Cooley’s Anemia Advocacy Forum Update: November 2015


November 4, 2015The Cooley’s Anemia Advocacy Forum (CAAF) is a Cooley’s Anemia Foundation project aimed at helping thalassemia patients and families learn how to make their voices heard on federal issues of importance to the thalassemia community.  (A brochure about CAAF can be downloaded by clicking here.)  Following is a report from Lyle Dennis and Katie Schubert.

10th Cooley’s Anemia Symposium a Resounding Success

Click here to read the report on the exciting 10th Cooley’s Anemia Symposium!

 

Congress Passes Sweeping Budget Deal

With just days to go before a potentially devastating default, Congress overwhelmingly adopted a bipartisan budget agreement that lifts the federal borrowing limit and clears the way for passage of a spending bill that funds the National Institutes of Health and the Centers for Disease Control and Prevention.

In a surprising display of cooperation, House and Senate leaders worked behind closed doors with President Obama to forge the Bipartisan Budget Act of 2015 (BBA), which raises the federal borrowing limit through March 2017. In addition to preventing a default on the federal debt, the measure also increases federal spending limits by $80 billion over the next two years.

The legislation more than pays for itself by: selling off 58 million barrels of oil from the Strategic Petroleum Reserve; auctioning off portions of the government-help electromagnetic spectrum; increases premiums companies must pay to the Pension Benefit Guaranty Corporation; and lowers the rate of return for crop insurance providers.

The BBA also eases the way for Congress to complete work on 12 appropriations bills over the next several weeks. It increases the FY 2016 discretionary spending cap by $50 billion and the FY 2017 cap by $30 billion, with the increases equally split each year between defense and non-defense spending.

The agreement gives the House and Senate Appropriations Committees just over one month to iron out their differences over the 12 government spending bills which are currently operating under a continuing resolution that expires December 11.

The text of the two year “Bipartisan Budget Act of 2015” agreed to is here. See also a section-by-section summary here.

 

NHC Calls for Dormant Therapies Exclusivity in Senate Health Bill

The National Health Council (NHC) is asking the Senate health committee to include a controversial 15-year exclusivity provision for dormant therapies in the panel’s Innovation for Healthier Americans initiative.

NHC recently wrote to committee Chair Lamar Alexander (R-TN) and Ranking Democrat Patty Murray (D-WA) urging  the senators to revive the measure, which was dropped from a companion House bill, 21st Century Cures.

NHC argues that current patent law discourages drug manufacturers from pursuing products addressing unmet medical needs that take a long time to develop because patent protections may not last very long after FDA approval of the product.

Under the proposed dormant therapies provision, manufacturers would be awarded 15 years of exclusivity that starts once FDA approves a treatment if the agency determines the product addresses an unmet medical need.

“Therefore, we strongly support the creation of an approval pathway for Dormant Therapies, which would remove technical patent requirements that are unrelated to medical promise and that would start the period of protection at the point of FDA approval. This pathway would incentivize researchers to pursue the development of drug compounds on the basis of their clinical promise, rather than their patent life,” NHC says in its letter to Alexander and Murray. 

The Generic Pharmaceutical Association came out strongly against the dormant therapies exclusivity provisions when they appeared in the initial discussion draft of the House Energy and Commerce Committee’s 21st Century Cures Act released in January, arguing that a 15-year exclusivity period would keep cheaper generic drugs out of the hands of patients for far too long. Other stakeholders pegged the exclusivity provisions in the Cures bill as a gift-bag for the brand-name pharmaceutical industry.

A myriad of exclusivity provisions were subsequently dropped from the Cures bill, with only the Orphan Product Extensions Now (OPEN) Act — which would grant an additional six months of exclusivity for approved drugs that receive a new indication for a rare disease or condition — making it back into the final version of the legislation.

While the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) are members of NHC, in its letter to Alexander and Murray the group says that patient advocacy groups are the core of its membership and control the governance of the organization.

NHC also asked the senators to provide mandatory increased funding for the National Institutes of Health in their upcoming innovation bill.

“Basic research conducted through NIH funding is the lifeblood of research to find new treatments and cures for people with chronic diseases and disabilities. As the HELP Committee works to craft legislation to bring lifesaving cures and treatments to patients, increasing the funding of NIH through mandatory spending should be a top priority,” NHC writes.

The House-passed Cures legislation provides $8.75 billion in mandatory funding to NIH over five years and $550 million in extra funding for FDA over the same time period.

At the same meeting Alexander told NIH Director Francis Collins that he is willing to think about mandatory funding because he is convinced “this is a critical time in science,” but Alexander questioned what would happen at the end of the five years of increased spending proposed in the House Cures bill, and if there is a distinct purpose that would justify mandatory funding.

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