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[e-drug] Senators introduce bill aimed at getting generic drugs to market

E-DRUG: Senators introduce bill aimed at getting generic drugs to market
[Although this message concerns the USA setting, we are aware that it is also 
necessary to counter big pharma misinformation about the safety and quality of 
generics in developing countries at times.  BS]

Life | Tue Jun 14, 2016 6:44pm EDT

Related: Election 2016, <http://www.reuters.com/politics/election2016> 
Politics, <http://www.reuters.com/politics> 

Senators introduce bill aimed at getting generic drugs to market

WASHINGTON | By Diane Bartz<http://www.reuters.com/journalists/diane-bartz>


WASHINGTON Four U.S. senators - two Democrats and two Republicans - introduced 
a bill on Tuesday aimed at preventing big pharmaceutical companies from using 
safety rules to prevent generic drugs from coming to market.

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, 

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 

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 

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 

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.

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)

Lucas F.M. van der Hoeven
Heuvel 20
5101 TD Dongen

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