Does this Proposed new Healthcare Law Hurt or Help Patients?

Guest Contributors: Diana Zuckerman, PhD, President and Paul Brown, Government Relations Manager  |  National Center for Health Research.  The National Center for Health Research is a nonprofit, nonpartisan research, education and advocacy organization that promotes the health and safety of adults and children.  http://center4research.org/

Patients have been actively lobbying for and against the 21st Century Cures Act.  There is a great deal of passion on both sides of the issue.  Here is what you need to know as you consider whether to contact your U.S. Senators about this bill.  

The Act passed the U.S. House of Representatives in July.  There was a lot of praise from patient organizations, well-known charities, and universities.  They were excited about the increase in funding for the NIH and optimistic that the bill would provide the cures to desperate patients.  

But at the same time that supporters claim the bill would save lives, other patient and consumer advocates point out that it would drastically lower FDA standards for new medical products.  That would make it easier for drug and medical device companies to sell more of their products more quickly, but unfortunately, many of those products will not be cures, or even be beneficial to patients.  Instead of moving us into the 21st century, many of us think the bill moves us back to the days before the tragedies from Thalidomide, DES, and the Dalkon Shield IUD resulted in FDA laws requiring scientific standards to protect patients from unsafe medical products.

Speed vs. Careful Review at the FDA.  The House's 21st Century Cures Act encourages the FDA to lower its standards so that companies can sell new drugs and devices to patients based on very preliminary evidence, such as rat studies and subjective information about just a few patients -including "case histories" of just one patient.  That would take us back to the early 20th century, to an era of snake oil salesmen.

 The 21st Century Cures Act would also take away FDA's authority to make sure medical software is accurate.  Innovative technology such as interactive electronic medical records can remind doctors about drug interactions and other dangers.  People's lives can depend on that software -- which tells patients or their doctors what tests a patient needs, whether they need more insulin immediately, etc.  It needs to be regulated by FDA to make sure it is accurate.  The House bill eliminates the FDA's authority to regulate most electronic software.  The Senate should not allow that to happen.

The House bill would allow companies to give doctors expensive gifts and travel funds without making those gifts public.  This rips a hole in the Physician Sunshine Act that the House and Senate previously supported.   The Senate should not allow it.

The House bill would allow companies that make potentially life-saving devices to make changes to the design or materials used without submitting them to the FDA for approval.Companies would just have to prove to a third party (paid for by the company itself) that they have good quality control mechanisms in place.   This concerns those of us who have seen how employees of even the best companies can overlook safety concerns when the bottom line is at stake.

This House bill would worsen antibiotic resistance. One section of the bill "encourages the development and use of new antimicrobial drugs." Unfortunately, the bill encourages the overuse of poorly tested new antibiotics, which means that bacteria would soon develop resistance to them.

We all want cures and we know that Congressional cuts in NIH funding have harmed medical research.  But Members of Congress need their constituents to remind them that FDA safeguards save lives every day.  A law that would enable unsafe drugs and devices to get FDA approval and be sold to unsuspecting patients is a very dangerous drug.   And we would all pay for it, when taxpayers support Medicare, Medicaid, and Veterans' healthcare, and when individuals pay for medical treatment and for health insurance.