Health Legislation

The Patient, Consumer, and Public Health Coalition, we strongly oppose efforts to delay or repeal the 2.3% excise tax on medical devices.  The excise tax was included in the Patient Protection and Affordable Care Act (ACA), so that it would help to pay for benefits such as affordable health insurance for currently uninsured and underinsured Americans.  The Affordable Care Act will greatly benefit medical device manufacturers because more patients and consumers will have coverage that will enable them to afford medical devices.

The Patient, Consumer, and Public Health Coalition, strongly urges CMS to release the Sunshine Act final regulations as quickly as possible.  Public interest groups and members of Congress agree that it is past time to release the regulations and start collecting information on industry payments to healthcare providers.

The Patient, Consumer, and Public Health Coalition thanks the HELP Committee for the opportunity to comment on draft legislation.

The Patient, Consumer, and Public Health Coalition thanks Congressman Markey on his commitment to the health of patients and consumers by introducing the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012.  This bill would strengthen FDA oversight of compounding pharmacies in several essential ways, and is clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths.

The Patient, Consumer, and Public Health Coalition writes to strongly oppose the use of ASTM International Standard (F1917-12) as a safety standard for baby bumper pads.  The standard is not a useful alternative to the Department of Health and Mental Hygiene’s (DHMH) proposed ban. 

The coalition advocates with Congress for increased funding for the FDA to ensure the agency has the resources it needs to carry out its mission of protecting and promoting the public health.

The nonprofit Patient, Consumer, and Public Health Coalition shares concerns about the need for new antibiotics. The Generating Antibiotic Incentives Now (GAIN) bill focuses on providing incentives to pharmaceutical companies, which is important. However, some antibiotics are much more important than others, and the bill may have unintended consequences for increasing AMR.

The Coaltion sends a letter to Secretary Sebelius on the proposed recommendations for PDUFA V, which includes hat most of the recommendations are aimed at industry perceived barriers to new drug approvals, rather than concerns about protecting and promoting the health of patients and consumers

The Coalition thanks the FDA for frank discussions about the Medical Device User Fee Act (MDUFA III) reauthorization process.This letter provides our comments and suggestions regarding the MDUFA III proposals put forth by industry and the FDA. It also includes a request for additional information about specific FDA
proposals.

As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Patient Protection and Affordable Care Act (ACA) and oppose efforts to undermine this essential program that will benefit millions of Americans.  In the upcoming negotiations over the budget and debt ceiling, we urge you to reject the repeal of the 2.3% excise tax on medical devices.