On Tuesday, Democrat and Republican senators introduced a bill designed to prevent big pharma groups from hampering generic drug competition.
The bill is set to solve the complaints of generic companies about the obstacles they meet when they try to develop generic drugs, or cheaper versions of brand-name drugs.
For instance, generic drug makers say that big Pharma groups abuse the rules set in place by the U.S. Food and Drug Administration under its REMS program to prevent them from manufacturing generic drugs.
Reportedly, big-name drug makers tweaked the drug-disposal program to work against smaller companies and prevent them from obtaining drug samples they need to produce generic drugs.
Generic drug makers have also complained for years that they lack access to a standard safety protocols so it is very difficult for their drugs to reach the market. Under the new rules, a generic drug maker would be allowed to file a civil lawsuit to get access to either a drug sample or a safety protocol.
Senator Charles Grassley, head of the Judiciary Committee and one of the sponsors of the bill, explained that the new rules are designed to find a balance between the tremendous costs of researching lifesaving drugs and the need of affordable drugs.
Sen. Grassley noted that “some” drug makers resort to unfair tactics to delay the entry of their drugs’ cheaper versions to the market. The senator also said that the bill was designed to prevent any attempt of frustrating the current laws.
The House has introduced a similar bill but the method of solving obstacles does not involve a court of law. Instead, generic companies are required to seek FDA’s approval for a REMS drug sample whenever they need one.
But legal battles related to REMS procedures are not new. Two years ago, the generic drug manufacturer Mylan Pharmaceuticals sued Celgene Corp because Celgene reportedly prevented it from getting access to Thalomid and Revlimid samples through REMS.
The Pharmaceutical Research and Manufacturers of America, which represents the most prominent drug manufacturers in the U.S., declined to comment. But the Generic Pharmaceutical Association hailed the new Senate bill.
GPhA’s head Chip Davis praised lawmakers for their interest in the cost-lowering role of generic drugs and noted that these anti-competitive practices are only driving healthcare system costs upward.
Image Source: Pixabay