Health Care Law Reform : Health Care Lawyer & Attorney : McDermott Will & Emery Law Firm : Managed Care, Product Regulations

The Facts 

The U.S. House Energy and Commerce Committee's health reform legislation, HR 3200, includes a provision to enable the U.S. Food and Drug Administration (FDA) approval of biological products as biosimilars under the Section 351 of the Public Health Service Act. By a vote of 47-11, the Committee adopted the Eshoo-Inslee-Barton amendment that, among other things, would protect original approval data for a minimum period of 12 years. Termed “data exclusivity,” it prevents potential competitors from relying on the innovator’s intellectual property, such as clinical trials supporting the safety and efficacy of the innovator product, to support FDA approval of a biosimilar product. 

What’s at Stake

The biosimilar language in HR 3200 is not identical to that agreed to in the health reform bill approved by the Senate HELP Committee. Consequently, there is an opening for additional changes to the provisions related to biosimilars during the House/Senate conference should health reform legislation containing these provisions be passed in both chambers. Stakeholders continue to advocate for changes related to the data exclusivity provisions, which are favored by the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America but opposed by the generics industry and AARP, which believe shorter exclusivity and more liberal patent protections are necessary to speed lower cost biologicals to patients.

Steps to Consider

Consider selected outreach to Congress or supporting your trade organization's efforts to advocate for more favorable accommodations in the ultimate legislative package. Determine the implications and corresponding business and legal risks from current legislative proposals. Identify steps to take prior to enactment of legislation to best position products going forward, including the following: 

• Reimbursement approaches
• Product nomenclature, marketing and labeling
• Issues related to “similar” or "interchangeable" products, including antitrust, intellectual property protection and potential litigation strategies
• Regulatory strategies for pipeline products

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The Facts
The Family Smoking Prevention and Tobacco Control Act was approved by Congress on June 12, 2009, and is on its way to President Obama. The bill for the first time gives the U.S. Food and Drug Administration (FDA) the power to regulate tobacco, but not ban tobacco products outright. The agency may also limit nicotine, but may not require it to be removed completely. Particular tobacco products, just like other FDA-regulated products, may be found to be “misbranded” or “adulterated” by FDA and subject to an array of enforcement actions, including seizure of the products. The new tobacco center will be partially funded by user fees, similarly to other centers. 

What’s at Stake
The act marks a significant shift in focus at FDA. The relative weight within FDA of the tobacco center compared to existing centers, such as those for drugs, devices or foods, has yet to be determined, but it will certainly absorb time, funds and senior talent. Tobacco is estimated to be responsible for 400,000 deaths per year, according to the Centers for Disease Control and Prevention, far more than any other single product FDA regulates, and as such is a critical public health issue. A lengthy conversation internally at FDA over balance among the centers will undoubtedly occur over the next months and years. The bill’s implementation will likely receive a great deal of attention from the No. 2 at the U.S. Department of Health and Human Services, Deputy Secretary Bill Corr, former executive director of the Campaign for Tobacco-Free Kids.

Steps to Consider
Because the new tobacco center at FDA may divert resources and focus from other centers, and may slow down initiatives (or possibly even approvals) at the drug, biologics or devices centers, interested parties should watch this space closely and stay alert to the potential impact on approvals and needed initiatives being carried out by FDA and its other centers.

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