Life Sciences Law Blog : Class Action Lawyer & Attorney : Sheppard Mullin Law Firm : Antitrust, Securities, Wage & Hour, Consumer Fraud

By Peter Reichertz

FDA has at last began formal implementation of the Biologics Price Competition and Innovation Act of 2009 ("BPCI Act"), by announcing the proposal it will send to Congress to implement user fees for "generic" copies of biologics, called biosimilars in the BPCI Act. A biosimilar is a product approved under Section 351(k) of the Public Health Service Act ("PHSA"); approvals are not Federal Food, Drug and Cosmetic Act ("FFDCA") approvals. Under the proposal, the user fees for biosimilars - including the product application fee, the annual product fee and the annual establishment fee - would be identical to the fees established for human drug products approved under Section 505(b) of the FFDCA with one significant difference.[1]

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By Seth A. Mailhot

On Friday, July 29, 2011, the Institute of Medicine of the National Academies (IOM) released its long awaited report on the premarket clearance process under section 510(k) of the Federal Food Drug and Cosmetic Act.[1] The premarket clearance submission, commonly known as a 510(k), allows manufacturers to market a medical device based on its similarity, or “substantial equivalence,” to one or more marketed devices (called “predicate devices”). The 510(k) process is the most widely used pathway for marketing medical devices through the U.S. Food and Drug Administration (“FDA”), and is intended for intermediate risk devices.[2] The report was anticipated to provide clear action items to the agency to strengthen the 510(k) process and make it more responsive to companies developing emerging medical technology. Instead, the recommendations made by the IOM committee only heighten the current uncertainty with the future direction of the 510(k) process.
 

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By Peter S. Reichertz

The Supreme Court ruled on June 23, 2011, that generic drug manufacturers cannot be sued for a failure to warn under state tort law, as long as their labeling complies with the FDA mandated labeling for the innovator drug product. While the Court had previously declined to find that federal regulation and approval of drug labeling of an innovator drug preempted state tort law in Wyeth v. Levine, 555 US 555 (2009), the Court ruled 5-4 in Pliva that the comprehensive scheme for approval of generic drugs under the 1984 Hatch-Waxman amendments required generic manufacturers to use the same labeling as the innovator brand name product. Since the law and FDA regulations, as conceded by the Food and Drug Administration (FDA), preclude a generic company from obtaining approval of labeling different from the innovator brand name product, the Court held it was not possible for a generic manufacturer to comply with both federal and state law. As such, under the doctrine of impossibility, they ruled federal law was supreme and state tort laws on failure to warn were preempted. In so finding, they held that the issue of “impossibility” turns on whether the private party could independently do under federal law what state law requires of it. In this case, they held that generic manufacturers could only ask FDA to change labeling and could not do so without FDA approval, and thus could not act independently.
 

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By Peter S. Reichertz and Allie Frumin

January 19, FDA announced its plan to modify the 510(k) “approval” pathway, the most common review path for medical devices. Specifically, FDA released a report containing twenty-five actions it intends to take in 2011 to “improve” the review process. Importantly, however, no changes have yet been made to the process; FDA has just announced its plan of action of how it intends to address potential changes to the process.
 

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By Deborah M. Shelton and Allie Frumin

On Tuesday December 7^th, the D.C. Circuit Court of Appeals affirmed a lower court’s ruling in Sottera, Inc. v. FDA, No. 10-5032, (D.C. Cir. Dec. 7, 2010) holding that that the Food and Drug Administration (FDA) could not regulate as a medical device the electronic cigarettes (often referred to as “e-cigarettes”) at issue in that case. Instead, the court affirmed the district court’s finding that FDA’s authority over these e-cigarettes, as labeled, was limited to that over traditional tobacco products.
 

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By Deborah M. Shelton

Having had the opportunity to analyze the biosimilars provisions of the new health care law enacted this past March, stakeholders have at long last the chance on November 2-3 to weigh in on FDA's implementation of the biosimilar approval pathway. FDA will hold a two-day public hearing on November 2-3, 2010, from 8:30 am to 4:30 pm, at the FDA Conference Center on FDA's campus in White Oak, Maryland.  FDA published its official announcement of the public hearing in the October 5^th issue of the Federal Register. 75 Fed. Reg. 61497 (Oct. 5, 2010). Here is the link to the Federal Register Notice: http://edocket.access.gpo.gov/2010/pdf/2010-24853.pdf.
 

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By Peter S. Reichertz, Brian D. Weimer and Daniel Brooks

Last week, the Federal Communications Commission ("FCC") and the Food and Drug Administration ("FDA") launched a joint initiative to clarify the approval process and regulatory requirements for converged communications and health care devices. In a two-day joint meeting held on July 26-27, 2010, the two agencies solicited comments from industry representatives "to gain a better understanding of the convergence of communications technologies and medical devices, the future of wireless health technologies, and the challenges they face." The goal of the initiative is "to enhance coordination between FDA and FCC for future devices and applications, and to clarify and delineate the respective areas of expertise and jurisdiction between the agencies."
 

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By Deborah M. Shelton

For years, the Food and Drug Administration has maintained that it has jurisdiction over laboratory-developed tests (“LDTs”) – those in vitro tests developed, validated and used for in-house pathology and diagnostic purposes – as medical devices. Yet the Agency has, with some few exceptions (e.g., IVDMIAs), exercised enforcement discretion, reasoning that most LDTs were simple, well-characterized, and reliant upon various FDA-regulated individual components. As LDTs have become increasingly complex and the laboratory setting increasingly large-scale, FDA has begun rethinking its regulatory approach.
 

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By Peter S. Reichertz

By letter dated May 27, 2010, the U.S. Trade Representative (“USTR”) sent a letter to the U.S. International Trade Commission (“ITC”) requesting that the ITC provide information about over 700 pharmaceutical products and chemical intermediates for which the elimination of custom duties may be proposed. As part of the “zero-for-zero” initiative of the Uruguay Round Agreements Act, the President can proclaim changes to duties for certain classes of goods as part of the “zero-for-zero” initiative. Pharmaceutical and chemical intermediates are in such categories. To date over 2,000 pharmaceutical products and intermediates have been added to the Pharmaceutical Appendix in the HTUS. The current review is the fourth periodic proposal to add additional pharmaceuticals and intermediates to the list. The United States and 21 other major trading countries agreed during the Uruguay Round to eliminate duties on pharmaceuticals and to periodically conduct reviews to identify additional products to be covered by the initiative. If added to the Appendix, the products included in the new USITC investigation would receive duty-free treatment.
 

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By Peter Reichertz

On May 19, 2010, FDA published on its website a series of proposals designed to promote “openness” and “transparency” in government. The document, entitled “FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the United States Food and Drug Administration” can be found here.  The document contains 21 specific proposals about changing the Agency’s policies of disclosure of information submitted to it and about interim decisions made by it.
 

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By Peter Reichertz

Manufacturers

As part of the recently enacted Patient Protection and Affordable Care Act (“PPACA”) – known to most as Healthcare Reform Legislation, new taxes will be imposed on manufacturers of “branded prescription drugs” and most medical devices. These taxes are in addition to the fees already charged by the Food and Drug Administration (“FDA”) for review of full new drug applications for drugs and 510(k)’s and Premarket Approval Applications for medical devices. And unlike user fees, the taxes will not be paid to FDA but assessed by the Department of Treasury and paid to support health insurance coverage.
 

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