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Victory on Biosimilars in Senate HELP Committee - But Still a Long Way from the Finish Line

July 14, 2009
Last evening the Senate Health, Education, Labor and Pensions (HELP) Committee adopted an amendment to the healthcare reform package that provided 12 years of data exclusivity for innovative biologics. This event was a significant victory for our companies and for patients. Two and a half years ago Senator Clinton and Congressman Waxman introduced bills that provided zero years of data exclusivity. Following extensive negotiations, Senators Kennedy, Enzi, Hatch, Schumer and Clinton agreed to a bill with 12 years of data exclusivity and it was reported from Committee in 2007.

While we hoped the deal would hold into the current session of Congress, we observed that Senator Schumer and others were backing away from the agreement. The AARP insisted in a communication to the Senators that it would not support a healthcare bill with double digit data exclusivity. The Federal Trade Commission (FTC) issued a report suggesting that innovators didn't need any data exclusivity and soon thereafter the Administration put out a letter supporting 7 years. On July 2 the HELP Committee staff reported that the base text of the bill would contain new language that would break the Kennedy/Enzi deal providing at most 9 years of data exclusivity only for new and innovative products and none for products that would have been approved by the FDA prior to the bills enactment. Products could receive an additional 3 years of data exclusivity if the sponsor could obtain FDA approval of a significant therapeutic advancement. This language was completely unacceptable. Certainly products already on the market deserve data exclusivity. And investors and manufacturers would have no way to predict in advance which products would qualify for the 9 year base exclusivity or the additional 3 years.

BIO staff, the staff of our companies' Washington offices, our consultants, our CEO's and our affiliates went into overdrive to regain support for the original 12-year deal. In discussion with Senate staff, in conversations with Senators and in advertisements we communicated the straightforward truth that without sufficient data exclusivity investment in biologics, R&D would dry up and the promise of new hope for patients would vanish.

Senators Hatch (UT), Enzi (WY) and Hagan (NC) offered an amendment that would restore the original agreement. Their leadership was masterful. Senator Mikulski (MD) was eloquent in the debate last evening. Ultimately we succeeded in defeating an amendment offered by Senator Brown (OH) that would have limited data exclusivity to 7 years and then winning support for the Hatch/Enzi/Hagan amendment by a vote of 16-7. It was a stunning victory that few would have predicted was possible less than two weeks ago.

We are still a long way from finished. We might face battles on the Senate floor as well as in the House. But so far, so good. We need to succeed. Lives are on the line.