Biogeneric Fights Looms In Congress
Make a commentBy Ed Silverman // July 12th, 2007 // 11:21 am
The House may have passed the FDA Amendments Act last night but some issues are far from settled. A big outstanding issue is what happens with biogenerics? The House bill doesn’t include a so-called pathway, which is included in the Senate version. And as The Wall Street Journal writes, it’s not clear whether House leaders, including Energy and Commerce Committee Chairman John Dingell, a Michigan Democrat, will compromise. Different House members have introduced divergent bills, but the Energy and Commerce Committee hasn’t moved forward with any of them, the paper notes.
In an interview yesterday with the paper, Mr. Dingell signaled that he will oppose inclusion of the copycat biotech-drug language in a final bill. Although he supports a pathway, he has safety concerns as well as questions about whether science is advanced enough to verify a copy’s similarity to the original medication. “There’s really no record to justify that kind of action” in the House, which hasn’t yet fully debated a bill, he told the Journal.
The issue is very important for the generics and biotech companies, and has been the focus of extensive lobbying. Currently, the FDA doesn’t have the power to approve generic versions of most biotech drugs, which have become some of the most important, and expensive, treatments, the paper writes, before adding that generics makers want the Senate language. Biotech makers, though, are expected to push for the House to consider its own bill, which could stall the change.