On Thursday, the Senate passed on a 96 to 1 vote for a new bill that will speed federal approval of medicines, including generics for biotechnology products. Vermont’s Senator Bernie Sanders was the sole “no” vote, saying the bill didn’t go far enough to reduce medicine costs.
The bill requires pharmaceutical and medical equipment companies to pay $6.4 billion over the next five years to pay for this fast-tracking of testing and approving new medicines and treatments. It also creates a new fee for review of generics and lower cost biotechnology devices. The House is considering a similar bill.
Fast tracking approval of medications is a tricky balancing act. Often, problems with new medicines do not become evident for years, because their ill effects are cumulative or the damage they do is slow and progressive. It took over a decade to learn that an osteoporosis medication causes slow, but deadly kidney damage. But medical devices and biotechnology should be fast tracked. The experience we have had with implants tells regulators what to look for. We have learned from things like leaking silicon breast implants and joint replacements that cause infections.
The bill also requires the drug industry to notify Congress if there is an imminent shortage of a drug. For Senate Majority Leader Harry Reid, that part of the bill was very personal. His wife, Landra, is undergoing treatment for breast cancer and the drug being used for her chemotherapy has suffered shortages in the past year. The bill would make it possible for searches to be conducted for alternative sources of drugs, such as in other countries.
The bill also requires the F.D.A to do studies of health-related software programs for smartphones and mobile devices, and inspections of foreign companies that provide drugs for importation into the United States. It increases criminal penalties for counterfeit drugs and provides for better tracking of drugs from manufacturer to patient.
The Congressional Budget Office is pleased with the bill. It should, according to their statement, “lead to earlier marketing of lower-priced drugs,” which would reduce costs to Medicaid, Medicare and subsidized health insurance policies in the Affordable Care Act by as much as $750 million over 10 years.