by guest blogger Diana Zuckerman, president of the National Research Center for Women & Families
It’s an election year and, despite our hopes for a better economy, even the best candidates can’t deliver on their promises to improve it. It’s a bigger issue than one person, however powerful. But they could health improve our health, if they wanted to.
Whatever the Supreme Court does about the Affordable Care Act, also known as ObamaCare or RomneyCare, the upcoming election will be important with regard to your health. The Supreme Court’s decision is out of our hands, but the court’s future decisions are not. Whoever is president will help shape future Supreme Court decisions, which will certainly continue to determine women’s access to reproductive care.
And, although Congress has accomplished almost nothing in the past year, the legislature is poised to pass a bipartisan bill that will affect all our health. It sailed through the Senate last week (96 to 1!) and a different version is likely to sail through the House soon. The two bills will then go to conference to work out the differences between the House and Senate versions. If you never heard of this bill, you should find out more.
The FDA Safety and Innovation Act, also known as the User Fee Bill, is a long, wonky bill that most people never heard of. Big Pharma, Medical Device Companies, the Society of Chemical Manufacturers and Affiliates, and the Generic Drug Industry are just a few of its supporters. Patient groups that are funded by any of those industries also support it. Consumer groups and public health nonprofit organizations, which are less likely to be funded by industry, support parts of the bill but are unhappy with many of its provisions. Here are a few of the reasons for support and dismay:
- The Food and Drug Administration (FDA) is a poorly funded federal agency that is responsible for regulating food, drugs (for humans and animals), vaccines, medical devices, cosmetics, and vitamins/dietary supplements. This legislation increases the user fees that companies pay when they submit new medical products for FDA approval. That money is desperately needed, so almost everyone who understands the importance of the FDA wants this bill to pass.
- The FDA has a two-year backlog of generic drugs that have been submitted to the agency for approval. Those generic drugs will be reviewed more quickly thanks to new user fees in this legislation, thus saving Medicare, Medicaid, insurance companies, and individuals a lot of money every year. That’s good too.
- Every year, counterfeit medications are sold to unsuspecting patients whose lives could be jeopardized as a result. This bill will help FDA do a better job of eliminating counterfeit medications.
- FDA’s job is to get safe and effective medical products to market as quickly as possible. Thanks to industry lobbying, this bill pushes for speed, but not for safety or effectiveness, including language that forces the agency to worry even more than it already does about “burdening” industry if FDA wants to ask for better evidence of safety or effectiveness to support companies’ applications.
- A section of the bill aimed at giving companies financial incentives to develop new antibiotics does so in a way that will definitely increase prices, but not necessarily save lives. The Senate version of this section of the bill (called the GAIN Act) focuses on lifesaving antibiotics (as it should), but the House version does not, thus doing more harm than good.
- FDA requires companies to conduct clinical trials to prove that prescription drugs are safe and effective, but the agency doesn’t require that clinical trials be completed for more than 95 percent of new medical devices, such as contact lenses, artificial hips, and heart defibrillators. In recent years, more than half a BILLION medical devices were recalled by the FDA because they were so dangerous they could kill or permanently harm patients. The bill does nothing to prevent that.
Given the opposition to the FDA of many Tea Party members of Congress, we are lucky the bill has some important improvements. It’s also good that it doesn’t weaken most of the FDA’s current safeguards for patients. But it could have been much better if so many members of Congress—especially conservatives, but also moderate and liberal members who were heavily lobbied by industry—hadn’t opposed new, additional safeguards. And while it’s in the conference between House and Senate in the next few weeks, the bill could get better or worse.
Diana Zuckerman is the president of the National Research Center for Women & Families. She received her PhD in psychology from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School. After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House. She is the author of five books, several book chapters, and dozens of articles in medical and academic journals, and in newspapers across the country.