Health Legislation

As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the Preventing Regulatory Overrreach To Enhance Care Technology (PROTECT) Act of 2014.  The Act, as drafted, would have the harmful consequence of exempting so-called “health software” and “clinical software” devices from FDA oversight.  Also, the Act is premature.  Congress is awaiting a study commissioned in 2012 to guide policymakers on this very issue.

We strongly oppose H.R. 3303, the SOFTWARE Act of 2013. The Act, as drafted, would have the harmful consequence of exempting so-called “health software” and “clinical software” devices from FDA oversight.  Also, the Act is premature.  Congress is awaiting a study commissioned in 2012 to guide lawmakers on this very issue.

The Patient, Consumer, and Public Health Coalition conditionally supports the draft guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (FD&C) because it clarifies FDA enforcement actions that can be taken against individuals or firms that illegally make drugs under the banner of traditional compounding.

We oppose H.J. Res 77 and any other efforts to single out the Food and Drug Administration for funding.  Our organizations represent millions of patients, consumers, health professionals, and scientists who strongly support the work of the FDA and urge Congress to provide the level of appropriations the agency needs throughout FY 2014.

We re very supportive of the Patient Protection and Affordable Care Act (ACA).  We were extremely disappointed that the Hatch-Klobuchar amendment (S. Amdt. 297 to S. Con. Res. 8 ) to repeal the 2.3% excise tax on medical devices was overwhelmingly supported. Thank you very much for your important vote against the amendment.  We are writing to ask for a meeting with your staff to discuss this issue.

The Coalition writes to Congresswoman DeLauro to strongly support the “Healthy Families Act”, which creates a national standard for paid sick days.

The Coalition writes to Chairman Tom Harikin to strongly support the “Healthy Families Act”, which creates a national standard for paid sick days.

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.