Mark Armstrong Quoted in Article About Biologics

Specialty Pharmacy News

Mark Armstrong, a Member of the Firm in the Health Care and Life Sciences practice in the Houston office, was featured in an article titled "President Reignites Biologics Exclusivity Battle With Proposal for Seven Years."

According to the article, President Obama's proposed HHS budget for fiscal year 2012 included a provision on an issue that pharmaceutical industry stakeholders thought had been settled through the health reform law. That law provides innovator biologics companies with 12 years of exclusivity — but the proposed budget suggests shortening that to seven years. While many industry experts agree that the provision probably will not supplant the one in the reform law, there are multiple takeaways from the entire situation.

If the exclusivity period were changed from 12 years to seven, said Armstrong, it "would mean significant savings to both Medicare and Medicaid funds. ... We're facing significant shortfalls, and this is an opportunity to diminish the shortfalls by allowing less expensive generic biologics onto the market. If biosimilars are approved earlier, they could reduce costs to patients and payers."

"I think there is going to be pressure to get this done because of the savings," Armstrong told SPN. "However, there will be difficulties in getting this done. Most manufacturers believed they had accepted a 12-year exclusivity period, and the rules of the game seem to have been changed a little."

Still, he said, "it's rational to think that if the administration believes they could save the Medicare Trust Fund the type of money they're saying in the budget, ... then I could see this getting passed."