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.

Quality & Compliance GMP

May 31, 2017

FDA Warns Drug Manufacturers of Recalls due to BCC Contamination

On Monday, May 22nd, the FDA issued a warning for drug manufacturers regarding the contamination risk posed by Burkholderia cepacia complex (BCC). According to FDA’s warning, “BCC and other...

Read the Full Article
Agency Alerts General Regulatory

April 18, 2017

Congress Drafts Bill to Extend the User Fee Programs for Drugs, Devices, Etc.

On Friday, April 14th, a draft bill was released, aimed at reauthorizing the user fee programs for branded and generic drugs, medical devices, and biosimilar products. Committees from the House of...

Read the Full Article
Agency Alerts General Regulatory

May 1, 2017

FDA Warns 14 Companies for Illegally Selling Fake Drugs Claiming to Cure Cancer

On Tuesday, April 25th, the FDA released warning letters that were recently issued to 14 US-based companies. These warning letters were issued with regards to the illegal sale of products that claim...

Read the Full Article