The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act and the Fair Access for Safe and Timely (FAST) Generics Act are being discussed in a legislative hearing today before the U.S. House Energy & Commerce Subcommittee on Health. The solutions contained in these market-based measures represent critical steps toward lowering prescription drug prices by spurring more competition and cracking-down on the anti-competitive tactics of Big Pharma. Two other measures being discussed at the legislative hearing today, Orange Book and Purple Book improvements, represent a step in the right direction to clean-up the patent process around prescription drugs.
This hearing in Congress marks positive progress toward getting key market-based solutions passed into law and continuing the conversation on tackling loopholes in the patent process.
For too long, brand-name drug makers have been gaming the system – using loopholes in the U.S. patent system to crush competition and make it difficult for generics and biosimilars to safely and fairly enter the market and compete.
These tactics are known and documented.
In May 2018, the U.S. Food and Drug Administration (FDA) created a public list of brand-name pharmaceutical manufacturers abusing FDA safety protocols or creating their own systems to waylay generic or biosimilar competitors from entering the marketplace. The FDA’s list found 164 instances covering more than 50 prescription drugs.
The gamesmanship of Big Pharma has created an absence of competition, causing drug prices to skyrocket and harming American patients.
Not only are measures like CREATES critical to securing relief for American patients and consumers – they enjoy widespread public support, bipartisan backing from policymakers and would save taxpayer dollars:
These solutions have been gaining significant bipartisan momentum in Congress and have received broad support from patient advocates and health care industry leaders.
When one in four Americans cannot afford their medication, we need market-based reforms now more than ever. CSRxP applauds the committee for continuing to keep focus on measures like the CREATES and FAST Generics Acts as well as other market-based solutions to the prescription drug price crisis.
 “S. 974, Creating and Restoring Equal Access to Equivalent Samples Act of 2018,” Congressional Budget Office, 9/18/18
 Patients For Affordable Drugs Now, “New Survey Shows HUGE Bipartisan Support for CREATES Act Legislation to Lower Drug Prices,” Press Release, 2/5/18