House Acts to Boost FDA Powers; Biotech Fight Looms


Just an update to the coverage (see here for details) I’ve given to the ongoing issue pertaining to generic biotech drugs, which impacts the possibility for generic insulin emerging, it now appears that Energy and Commerce Committee Chairman John Dingell, a Michigan Democrat, could be a key figure in the House in terms of getting this legislation passed in a timely fashion (right now, he now appears to be a roadblock … urgh!). If anyone lives in Michigan, an e-mail or phone call to your representative’s office could go a long way towards speeding this process up. You can tell him that you support the “Access to Lifesaving Medicine Act” (S. 623/H.R. 1038) pretty much as it has been written by the Senate. The main exceptions might be the 12-year exclusivity period vs. only 7 for regular, small-molecule drugs. After all, why should biotech drug makes enjoy longer patent protection, their development costs are not necessarily higher than for regular drugs. The key is to note your concern about the fact that he is standing in the way of similar legislation moving forward in the House. If his staff members ask, you should certainly tell them why … that as a person with diabetes, you are being denied access to generic competition in the insulin market because the FDA has not moved forward on the issue, but legislation would force the Agency to do something they have promised to do since 2001!

Anyway, this article was from this morning’s Wall Street Journal, and I thought you might find it relevant.

House Acts to Boost FDA Powers; Biotech Fight Looms
By Anna Wilde Mathews, The Wall Street Journal
July 12, 2007; Page A2

Washington - The House passed legislation that would bolster the powers of the Food and Drug Administration, but the vote sets up a confrontation with the Senate over whether to create a pathway for generic versions of biotechnology drugs.

The House FDA bill, approved 403-16, mostly parallels a bill that passed the Senate in May. Both versions would devote more money to monitoring the safety of marketed drugs and increase the agency’s authority over medications that raise safety concerns. The agency would have the clear ability to order follow-up studies, restrict distribution and enforce changes to the medications’ labels. The bills don’t grant the FDA the power to force a moratorium on direct-to-consumer advertising, a tough restriction that was discussed earlier, though the agency would be able to levy fines for false and misleading promotions.

A compromise version of the two measures is expected to be completed in the next few months – perhaps before the August recess – because the legislation renews industry fees that fund much of the FDA’s work. Both the House and Senate versions would also force drug companies to make public information from many clinical trials.

But there is a key divide between the Senate and House bills: the Senate will include language that creates a pathway for the FDA to approve copycat versions of biotech drugs, and the House bill doesn’t address the issue. The Senate provisions reflect an agreement among a group of key senators including Democrat Edward Kennedy of Massachusetts and Republican Michael Enzi of Wyoming, the health-committee leaders.

Mr. Kennedy has said he will introduce that compromise, which was reached after the Senate passed its FDA bill, as part of the proceedings of the bicameral conference committee that will resolve differences between the House and Senate proposals.

A key question is whether House leaders, including Energy and Commerce Committee Chairman John Dingell, a Michigan Democrat, will be willing to accept the move. Different House members have introduced divergent bills, but the Energy and Commerce Committee hasn’t moved forward with any of them.

In an interview yesterday, Mr. Dingell signaled that he will oppose inclusion of the copycat biotech-drug language in a final bill. He said he supports a pathway for such drugs, but 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 said.

The issue is extremely important for the generics and biotech industries, and it 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. Generics makers will prod for inclusion f the Senate generic-biotech language. Biotech makers, though, are expected to push for the House to consider its own bill, which could stall the change.

A spokesman for the Biotechnology Industry Organization said "it’s a complex issue, and it deserves full and deliberate consideration."

A spokeswoman for the Generic Pharmaceutical Association said in an e-mail that the group is “cautiously optimistic” that the copycat-biotech provisions will be in the final FDA legislation.

Write to Anna Wilde Mathews at

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