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 Senators Charles Grassley, chair of the Judiciary Committee, and
Patrick Leahy, the top Democrat, are sponsors of the bill along with
Senators Mike Lee and Amy Klobuchar, the chair of the antitrust
subcommittee and top Democrat, respectively.
The Food and Drug Administration, which ensures the safety of the
country's food and drug supply, has a risk evaluation and mitigation
strategy program, called REMS, which is designed to ensure that the
riskiest drugs are dispensed safely.
But there have been complaints that the program has been misused by
brand-name drug companies to prevent generic manufacturers from
getting the drug samples needed to market cheaper versions. Generic
companies also complain their drugs are not allowed to share a
safety protocol, making it difficult to come to market.
The bill would allow a generic manufacturer who faces either of
these situations to file a lawsuit to force access to a sample or
force negotiations for a safety protocol.
"Balancing the cost of developing lifesaving medications with the
need to make available affordable prescription drugs to consumers
has always been a difficult task. It's a consistent topic at my town
meetings," Grassley said in a statement.
"Unfortunately, we're seeing some brand-name drug companies engage
in anti-competitive tactics that delay entry of lower cost generic
drugs into the market. This bill takes important steps to ensure
that our laws are not frustrated."
There is a similar bill in the House of Representatives which
addresses the same issue but uses a different strategy. For example,
it requires the generic company seeking a REMS drug to get FDA
authorization to obtain the sample.
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In one of the REMS disputes which is public, Mylan Pharmaceuticals
filed a lawsuit in 2014 against Celgene Corp, accusing it of using
REMS to prevent generic copies of Thalomid and Revlimid to market.
The Senate Judiciary Committee's antitrust panel will hold a hearing
on its bill on June 21.
The Pharmaceutical Research and Manufacturers of America, or PhRMA,
which counts major drugmakers among its members, said it had no
immediate comment.
The Generic Pharmaceutical Association was pleased to see the bill
introduced.
"It is worth noting and recognizing recent efforts by
representatives in the branded industry to highlight the valuable
role generic medicines play in driving healthcare system savings,"
said Chip Davis, GPhA's president. "Continued use of these
anticompetitive practices by certain manufacturers drives the exact
opposite outcome."
(Reporting by Diane Bartz, editing by G Crosse)
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