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# Grassley Promotes Bill Addressing REMS ‘Gaming’
- URL: https://www.fdaweb.com/grassley-promotes-bill-addressing-rems-gaming/
- Published: 2017-06-21T12:00:00.000Z
- Updated: 2026-09-14T22:30:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138986

Sen. **Charles Grassley** (R-IA) says he and several colleagues have introduced the Creating and Restoring Access to Equivalent Samples (CREATES) Act (S. 974) to help FDA address REMS program abuse in which brand drug manufacturers restrict generic manufacturer access to samples for product testing and refuse to enter into single, shared distribution system protocols with generic manufacturers. Grassley [wrote](https://www.grassley.senate.gov/news/news-releases/grassley-encourages-fda-commissioner-consider-proposals-expand-access-affordable?ref=fdaweb.com) to FDA commissioner **Scott Gottlieb** on the day the commissioner [announced](http://fdaweb.com/login.php?sa=v&aid=D5138984&cate=&stid=%241%24Pu0.s62.%24Tdb2%2FnWZadKytzFy4wScm1&ref=fdaweb.com) a 7/18 public meeting on the subject.

According to Grassley, the bill would deter drug companies from denying samples to generic companies, so they can conduct testing to produce cheaper generic alternatives. It also would give FDA more flexibility in making single, shared distribution system determinations.

The letter says the senator also is concerned about situations in which innovator and generic drug companies enter into agreements in which the innovator pays the generic not to compete as part of a settlement. He says that another bill, the Preserve Access to Affordable Generics Act ([S. 124](https://www.congress.gov/bill/115th-congress/senate-bill/124?q=%7B%22search%22%3A%5B%22S124%22%5D%7D&r=1&ref=fdaweb.com)) , would crack down on such anti-competitive payoffs.

“I hope you will take a close look at these two bills as you formulate your strategy to address accessibility and the high cost of prescription drugs,” Grassley concludes. “Your support for these bills will help in our shared goal of increasing access and lowering the price of drugs.”