WASHINGTON – The Senate Judiciary Committee Thursday approved the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act by a strong bipartisan vote of 16 to 5. The legislation, sponsored by Senator Patrick Leahy (D-Vt.) and cosponsored by Judiciary Committee Chairman Chuck Grassley (R-Iowa), would combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block lower-cost generic drugs.
Drug prices are rising rapidly and nearly one in four patients say they have not filled a prescription because of the cost. Currently, some bad actors among brand-name pharmaceutical companies employ tactics to block or delay competing generic drugs from entering the market. Two common delay tactics include brand-name companies preventing potential generic competitors from obtaining samples to perform necessary testing or participating in a shared safety protocol. The CREATES Act would allow generic drug manufacturers that are unable to obtain the samples necessary to gain FDA approval to file for injunctive relief in federal court. The Leahy-Grassley bill has an even number of Republican and Democratic cosponsors – 14 on each side – for a total of 29 cosponsors including chief sponsor Leahy.
The Congressional Budget Office has estimated that the bill would result in a $3.8 billion net decrease in the federal deficit. Savings to consumers and private insurers likely would be far greater.
“Families in Vermont and around the country are crying out for relief from skyrocketing drug prices. This bill is a sensible and meaningful step toward lowering the cost of prescription drugs by reigning in the predatory practices of some massive drug companies. Delaying strategies against generics are not only wrong, they do real harm. No American should have to decide between buying the medicine they need or food for their family. Momentum for our bill will now continue to grow after this strong bipartisan vote. We will continue to work toward getting it to the President’s desk,” Leahy said.
“Anti-competitive behavior by some brand-name pharmaceutical companies to block lower cost alternatives hurts consumers and costs taxpayers billions. The bipartisan CREATES Act is a free market solution that respects intellectual property rights and encourages greater competition that will inevitably lower the price of prescription medications for the American patient. It also saves $3.8 billion in taxpayer dollars and likely far more for consumers and private insurers. I look forward to getting this important tool passed so we can improve access to lower-cost generic drugs,” Grassley said.
The legislation, a version of which has been introduced in the House, is also cosponsored by Senate Judiciary Committee Ranking Member Dianne Feinstein (D-Calif.) and Judiciary Committee members, Senators Amy Klobuchar (D-Minn.), Mike Lee (R-Utah), Richard Blumenthal (D-Conn.), Sheldon Whitehouse (D-R.I.), Dick Durbin (D-Ill.), Ted Cruz (R-Texas), John Kennedy (R-La.) and Lindsey Graham (R-S.C.). The bill also has more than 80 organizations that support its passage.
Committee approval is a crucial first step toward the CREATES Act becoming law. The bill is also before the House of Representatives for consideration.