We may have saved the Affordable Care Act – for now – but rest assured the GOP Congress will continue to do everything in its power to screw the American people for the benefit of for-profit health care and the pharmaceutical industry. The latest: a cloture filing by Senate Majority Leader Mitch McConnell ending debate on the FDA Reauthorization Act of 2017 – part of which will hand over $11.6 billion to Big Pharma.
At the heart of this boondoggle is an attachment to the bill, known as the “Orphan Product Extensions Now Accelerating Cures and Treatments,” or OPEN-ACT. Introduced by GOP Senator Orrin Hatch of Utah, this legislation has existed since 2014, and was considered an important component of the so-called “21st Century Cures Act.” The provision was removed before the 21st Century Cures Act was signed into law by President Obama last December. Ostensibly, this provision was put into place in order to “incentivize” pharmaceutical companies to make these drugs available more quickly., However, what it essentially does is make it legal for pharmaceutical companies to engage in even more price gouging.
The OPEN-ACT is modeled after similar regulations governing pediatric drugs, which was part of the 1997 FDA Modernization Act (FDAMA). Those provisions were intended to give drug companies incentives to develop “safe and effective therapies” for young patients by extending their patents on such drugs for six months – provided that the manufacturers have solid, scientific evidence that said medications are indeed “safe and effective.”