Over the past year, Congress has taken several actions (or inactions) that seemingly nobody wanted; indiscriminately slashing budgets as part of the Sequester and shutting down the government for 16 days.
Unfortunately, the rare disease community has not been immune to the consequences of these reckless endeavors. As part of the Sequester, the FDA is unable to access user fees paid by industry members to strengthen the drug review process. Over $80 million in user fees were inaccessible to the FDA this year, thus threatening access to life-altering and often lifesaving drugs. Inaction will only strengthen the blow in 2014.
The Sequester also slashed funding for the Orphan Product Research Grant Program from $14.1 million to $12.9 million. This program has been absolutely invaluable in bringing treatments to market by funding over 530 trials that resulted in the approval of 50 orphan products.
Finally, the government shutdown prevented the FDA from accepting new drug applications, delaying the review process for new orphan treatments. The shutdown also prevented the NIH from accepting new applicants into their clinical trials.
As part of the deal struck to end the October government shutdown, a Budget Conference Committee has been formed to try to find a common ground. This bipartisan, bicameral committee has been charged, among other things, with tackling the Sequester. This Committee could also include tax reform measures in their final proposal.
So it’s time for the rare disease community to make its voice heard. If you live in the district or state of one of the representatives or senators on the Budget Conference Committee, join NORD in imploring them to replace the Sequester with a more balanced approach that does not slash research for orphan therapies and prevent the FDA from accessing industry user fees. The Budget Conference Committee also must protect the orphan drug tax credit from harm.
Follow this link and enter your zip code to see if your member of Congress is deliberating on these critical issues, and make your voice heard on Capitol Hill. If you do not reside in a district or state represented on the Budget Conference Committee, stay tuned, as the Conference Committee’s recommendations will reach your members of Congress soon.
Read a letter NORD sent to the Budget Conference Committee here.
RareDisease Dialog is the official blog for the National Organization for Rare Disorders (NORD). NORD’s staff and friends will share information of interest to the entire rare disease community.
Translate This page:
SUBSCRIBE TO OUR E-NEWS