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.
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.
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.
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.
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.
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
that support its passage.
approval is a crucial first step toward the CREATES Act becoming law. The
bill is also before the House of Representatives for consideration.
An outline of the CREATES Act can be
and the text of the bill, as introduced, can be found here