CREATES Act Reintroduced in House & Senate

May 4, 2017

CREATES Bill Reintroduced in House & Senate to Improve Access to Generic Drugs

On Thursday, April 27th, the “Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was reintroduced by members of the Senate & House Judiciary Committees.  The CREATES Act is a bipartisan bill intended to “combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block entry of lower-cost generic drugs.”

The bill was initially introduced in June 2016 by members of the Senate Judiciary Committee, and was reintroduced in the Senate and House of Representatives last week.  The revived version of the bill focuses on sample sharing as well as shared safety protocols.

If signed into law, the CREATES Act would allow generic manufactures to bring an action in federal court to obtain the samples that are needed in generic drug development.  Additionally, the bill would also authorize judges to award damages to the generic companies to avoid any delays from occurring in the future.

The bill is sponsored by Senator Patrick Leahy (D – VT), and co-sponsored by Senators Chuck Grassley (R – IA), Dianne Feinstein (D – CA), Amy Klobuchar (D – MN), and Mike Lee (R – UT).  In addition, Representatives Tom Marino (R – PA) and David Cicilline (D – RI) are also co-sponsoring an identical bill, which was introduced in the House on the same day.

If passed, the CREATES Act would produce a lot of opportunities for generic drug manufacturers. It will be very interesting to see what the future holds for the bill.

Are you in the process of developing a generic drug? We can help you obtain FDA approval for your product.  Contact us today to learn more about our services and how we can help you.

TAGS:

Whole Foods Receives Warning from FDA for Numerous Violations at Manufacturing Facility

On Wednesday, June 8th, the FDA issued a warning letter to Whole Foods Markets Inc., citing the company’s Everett, Massachusetts manufacturing facility for several GMP violations. The violations...

February 15, 2017

Indian API Manufacturer Fails to Correct Significant GMP Deviations, Receives FDA Warning Letter

In May 2016, the FDA inspected Resonance Laboratories Pvt. Ltd.’s Bangalore manufacturing facility. During this inspection, the FDA investigator observed a number of significant deviations from...

May 2, 2016

CBER Releases eSubmitter Program for Reporting Vaccine Adverse Events

On Friday, April 29th, FDA’s Center for Biologics Evaluation and Research (CBER) announced the availability of a new program supporting the submission of vaccine adverse event information. The...