Life Sciences Legal Update : Life Sciences Lawyers & Attorneys : Reed Smith Law Firm : Healthcare, Food and Drug Law, Biotechnology, Privacy, Product Liability

This post was written by Joseph W. Metro and  David E. Dopf .

The New Jersey Department of Human Services (“Department”) has sent letters to numerous pharmaceutical manufacturers demanding rebate payments under the Work First New Jersey General Public Assistance/Medicare Part D Wraparound Drug Rebate Program (“GA Rebate Program”). The Department is seeking to collect payments from manufacturers that have chosen not to participate in the GA Rebate Program and thus never entered into a GA Rebate Program agreement with the Department (“Rebate Agreement”). In addition, for some manufacturers that have entered into Rebate Agreements, the Department is now seeking payments for time periods prior to the effective dates of those Rebate Agreements.

The Department’s demand letters have uniformly provided the manufacturers with the option of requesting, within twenty (20) days from their receipt of the letter, either a pre-hearing conference for purposes of trying to resolve the payment dispute or a formal hearing before the New Jersey Office of Administrative Law (“OAL”). Manufacturers choosing to pursue a pre-hearing conference can still request a hearing before the OAL within twenty (20) days from the date of the pre-hearing conference if the dispute is not resolved.

We believe there are very strong arguments in support of the position that a manufacturer cannot be liable for payments under the GA Rebate Program in the absence of a Rebate Agreement covering the time period for which the payments relate. Please contact Joe Metro or David Dopf if you have any questions regarding the Department’s actions or would like assistance challenging the Department’s demand for payment.
 

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This post was written by Jennifer A. Goldstein and Areta L. Kupchyk.

On January 19, 2011, FDA announced its long-awaited plans for revising the premarket notification (510(k)) process for medical devices to address the concerns that have been raised about the process by industry, consumers and Center for Devices and Radiological Health (CDRH) staff regarding the lack of predictability, consistency, transparency of the process, the inadequacy of the process to ensure the safety and effectiveness of products, and the lack of flexibility of the process to address changing technology and complexity. In 2009, CDRH established working groups to address these concerns. In August 2010, these working groups issued recommendations, which FDA analyzed and addressed as part of the announcement. FDA also sought public input and comments.

FDA’s Plan of Action for 510(k)s includes 25 action items for 2011, which include the majority of the working group recommendations that received overall support from the comments submitted to FDA. FDA states that it will focus first on implementing steps that will significantly impact fostering medical device innovation, enhancing regulatory predictability and improving patient safety. These steps include streamlining the review process for innovative, lower risk products (the “de novo” process), improving training for CDRH staff and industry, increase reliance on external experts, as well as addressing and improving CDRH processes. The Plan of Action includes an ambitious agenda to publish eight specific draft guidance documents between June – December 2011, on topics including:

1. What changes do or do not warrant submission of a new 510(k) and which modifications are eligible for a Special 510(k);
2. Clinical trials;
3. Class III designation (de novo);
4. Appropriate use of consensus standards;
5. Appealing CDRH decisions;
6. The 510(k) paradigm, to provide clarity on when clinical data should be submitted, submission of photographs or schematics, appropriate use of multiple predicates, criteria for identifying “different questions of safety and effectiveness,” resolving discrepancies between the 510(k) flowchart and the Federal Food, Drug, and Cosmetic Act, “intended use,” and 510(k) summaries;
7. Pre-submission interactions with CDRH; and
8. Product codes.

FDA announced that it intends to implement other recommendations, but only after stakeholder input. These recommendations include developing an online repository of medical device labeling and a public database of cleared devices that includes a photograph of each cleared device, while avoiding the disclosure of proprietary information.  FDA also stated that it will further explore some of the other working group recommendations.

Finally, FDA identified some of the working group recommendations that were more controversial, such as consolidating the terms “indication for use” and “intended use,” expanding FDA statutory authority to consider off-label use when determining the intended use of a device and to require postmarket surveillance studies as a condition of clearance for certain devices, among others. FDA stated it will wait to decide whether to implement these recommendations until it receives feedback from the Institute of Medicine (IOM) as part of the IOM independent review of the 510(k) program that is currently underway. 

Click here to view a copy of the Plan of Action for Implementation of 510(k) and Science Recommendations, which includes a description of the action item and date of completion.

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FDA has issued a press release on its plan to reform the 510(k) medical device review process, outlining changes it intends to implement during 2011 including streamlining the “de novo” review process for certain innovative, lower-risk medical devices; clarifying when clinical data should be submitted in a premarket submission; and "establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making." Undoubtedly there will be much more on this in the coming weeks and months.

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This post was written by Ruth N. Holzman, Angelo Ciavarella, Joseph W. Metro and Vicky G. Gormanly.

On January 14, 2011, the Internal Revenue Service ("IRS") issued Notice 2011-9 (the "Notice"), which extended the filing date for reporting on Form 8947 a covered entity's 2009 sales of branded prescription drugs under the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the "Affordable Care Act" or the "ACA"). The filing date for Form 8947 with respect to 2009 sales of branded prescription drugs was extended from January 20, 2011 to February 11, 2011. In addition, in response to numerous comments received by the IRS, the Notice made certain changes to Notice 2010-71, 2010-50 IRB (the "Initial Notice"), primarily with respect to the information requested from covered entities. Please click here to view the full alert prepared by Reed Smith Tax and Life Sciences Health Industry attorneys.

On November 29, 2010, the IRS issued the Initial Notice, which provided guidance on the calculation of the annual fee imposed on certain manufacturers and importers of branded prescription drugs for calendar years beginning after December 31, 2010. Click here to view Reed Smith's previous alert which includes a detailed description of the Initial Notice, including the definitions of "branded prescription drugs," "covered entity," "Sales Year" and "Fee Year."

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