Urge Congress to Support $32 billion for the NIH in 2014

FASEB ACTION ALERT:  The Senate Appropriations Committee is expected to consider the Labor, Health and Human Services (LHHS) bill that will provide fiscal year (FY) 2014 funding for the National Institutes of Health (NIH). Although we don’t know when the House Appropriations Committee will vote on NIH funding, the spending limits in the House Budget Resolution could mean another 18 percent cut for biomedical research – below sequestration! NIH needs $32 billion in FY 2014 to prevent further erosion of the nation’s capacity for biomedical research and provide funding for additional grantees.

Read more

Debate on NPR: Is The FDA’s Caution Hazardous To Our Health?

When it comes to approving new medical treatments, the Food and Drug Administration is balancing the need for patient safety against the urgency of making important new available as quickly as possible.

Read more

Rare Disease Patient Sign-on Letter for Essential Health Benefits

Obama Care Implementation:  Sign on to Ensure Rare Diseases Patients have access to needed treatments, physicians and specialists in new Health Insurance Exchanges

Deadline to sign on is COB Friday, May 31st.

Read more

Medicare Part B – Ensure Medicare payments for providers of drugs and biologics

An informal coalition is working with the American Life Sciences Innovation Council (ALSIC) to protect Medicare Part B against cuts, especially for injectables or drugs administered by physicians for cancer, arthritis, rare diseases and other conditions.

Read more

Sign on to protect the Preexisting Condition Insurance Plan

The PCIP program is a critically important component of the ACA market reforms because it affords those patients that currently lack insurance coverage due to these discriminatory practices an opportunity to enjoy temporary coverage until they can transition to meaningful coverage on January 1, 2014.   To sign onto the letter please contact Jen Bernstein at jbernstein@jcwhiteconsulting.com buy April 15th 1pm Eastern.

Read more

Sign on to ensure patients receive cost-effective care

The National Health Council is urging organizations to sign onto a letter to add their voice to ensure patients receive cost-effective care under the Affordable Care Act (ACA).  If your organization would like to join the NHC in opposing the DOL’s decision to increase the out-of-pocket costs many patients must pay, please contact Eric Gascho at egascho@nhcouncil.org to have your organization added to the letter. Deadline for signature is close of business on Monday, April 15.

Read more

Protect Health Funding, click here

A letter is being circulated throughout the health, education, and workforce communities—urging appropriators to provide the Labor-HHS-Education Appropriations Subcommittees the largest possible “302(b)” allocation in FY 2014. 550 signers to date are listed on the letter. The list of signers has not been fully proofed and double checked, so please don’t share this with press or the hill.

Click to view the letter: 302(b) with signers

Click Here to add your organization to the letter!

Read more

Action Alert from the Council for Affordable Health Coverage

As you may know, legitimate concerns over an exploding federal budget deficit and looming fiscal cliff have prompted some Members of Congress and the Obama Administration to propose changes to Medicare. One proposal, mandatory rebates on drugs purchased by lower income Medicare beneficiaries, could increase Part D premiums by 20 to 40 percent.

Read more

Congressional Cystic Fibrosis Caucus

Edward Markey of Massachusetts, Cliff Stearns of Florida, and Tom Marino of Pennsylvania provide bipartisan leadership as co-chairs of the Caucus.

Read more


Department of Health and Human Services, OFFICE OF INSPECTOR GENERAL  MAY 2001

PURPOSE:  The purpose of this inspection was to assess the implementation of the Orphan Drug Act of 1983 and its impact on industry and patients.

Congress passed the Orphan Drug Act of 1983 to stimulate the development of drugs for rare diseases. A rare disease is defined as a disease that affects fewer than 200,000 people in the United States. Prior to passage of this historic legislation, private industry had little incentive to invest money in the development of treatments for small patient populations, because the drugs were expected to be unprofitable. The law provides 7-year marketing exclusivity to sponsors of approved orphan products, a tax credit of 50 percent of the cost of conducting human clinical testing, and research grants for clinical testing of new therapies to treat orphan diseases. Exclusive marketing rights limit competition by preventing other companies from marketing the same version of the drug, unless they can prove clinical superiority.

Read more