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3 Things to Know about the CREATES Act of 2016

September 27, 2016 // News

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Senator Patrick Leahy, a Democrat from Vermont sponsored the CREATES Act of 2016 (Creating and Restoring Equal Access to Equivalent Samples Act). It was referred to Committee on June 14, 2016, and has received bipartisan support.

Supporters of the bill say it will promote market competition by allowing access to drug samples for use in regulatory testing, while protecting the intellectual property for manufacturers. The bill was developed partly in response to Turing Pharmaceutical’s 2015 handling of the drug Daraprim, an antimalarial class of drugs used to treat infections and toxoplasmosis. The company inflated the price of the drug by more than 5000% and prevented generic developers from obtaining samples.

Despite the fact that opponents argue that the bill will make government drug approval even more-expensive – and may encourage patent lawsuits due to its threat to patent owners – the Federal Trade Commission (FTC) has cited concerns over long delays in getting generic drugs through the Food and Drug Administration (FDA) approval process and into the hands of consumers. Generic drugs are typically significantly less expensive than brand name drugs, although they are chemically identical to the brand name.

  1. The bill would expedite the ability of generic product developers to obtain the necessary quantities of drugs needed to allow them to produce generic products for FDA approval, and allow for a single, shared system to avoid delays in the process.
  2. The bill allows for civil action against the license holder of a covered drug product if they fail to provide samples. Remedies would include attorney fees and monetary awards.
  3. The Congressional Budget Office (CBO) has estimated the bill would result in more than $2 billion in direct savings over a 10 year period, with savings for consumers even more. 1 in 4 people do not fill prescriptions due to the cost of the medication.

To Read the CREATES Act of 2016 Fact Sheet visit: https://www.leahy.senate.gov/imo/media/doc/CREATES%20Act%20-%20One%20Pager%20for%20Press%20Release.pdf

To Read the Bill S.3056 CREATES Act of 2016 visit: https://www.govtrack.us/congress/bills/114/s3056/text

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