US: Lawmakers seek to block Rx Firms from delaying generics

Lawmakers are seeking to enact legislation that would stop branded drug companies from using FDA-mandated risk plans to block generic companies from obtaining drug samples for testing.

The Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights held a hearing June 21 on the proposed Creating and Restoring Equal Access to Equivalent Samples Act.

The bill would make it easier for generic drug companies to bring federal court cases and receive damages if they believe branded drugmakers are using a Food and Drug Administration-mandated risk evaluation and mitigation strategy for certain drugs as a reason to thwart generic drugmakers’ access to drug samples for testing. The FDA sometimes imposes a REMS on a drug or class of drugs to ensure the benefits outweigh the risks.

Sen. Charles Grassley (R-Iowa), a co-sponsor of the bill, said he is concerned that brand companies “are using an FDA regulatory process set up as a safety measure to block generic competition.” Grassley and other lawmakers said they are concerned about prescription drug prices and that competition from generic drugs lowers prices.

The panel didn’t discuss when it would vote on the bill, which was introduced a week ago.

Full Content: BNA

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