By Peter S. Reichertz
On August 9, 2010, the Food and Drug Administration (“FDA”) published a notice announcing a public meeting to be held September 17, 2010, “to gather stakeholder input on the development of a generic drug user fee program.” See 75 Fed. Reg. 47,820-21. FDA also requested submission of written comments on issues relating to assessment of user fees for generic drugs, which can be submitted by no later than October 17, 2010.
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."
By Peter Reichertz
On July 14, 2010, Congressman Edolphus Towns introduced legislation to provide for the mandatory recall of adulterated or misbranded drugs. The legislation, H.R. 5740, has been referred to the Committee on Energy Commerce. Congressman Towns was the chair of the subcommittee that held hearings about Johnson & Johnson/McNeil and its handling of adulterated children’s drug products (including Tylenol® and Motrin®) this past Spring. Johnson & Johnson was scrutinized for delaying the recall of the products and allegedly covering up the recall of some of the products. As a result, there has been increased publicity over the authority of the U.S. Food and Drug Administration (“FDA”) to require the recall of drug products.
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.
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.
By Doug Van Gessel
Introduction
Biotechnology laboratory facility leases present unique commercial leasing issues that landlords and tenants should anticipate if they are to achieve successful leases. A diverse industry group, biotechnology companies encompass pharmaceuticals, life sciences, medical devices, medical diagnostics, bioinformatics, biotechnology, and other biosciences and related services companies. The facilities requirements in this varied group cover a broad spectrum. At one end, startup companies are looking for small incubator or generic lab space; at the other end, "Big Pharma" and well-funded biotech companies face complex issues associated with large build-to-suit projects.
By Robert Magielnicki
In a recent interview, Senator Herb Kohl (D-Wis.), Chairman of the Senate Judiciary Committee's subcommittee on antitrust, competition policy and consumer rights, discussed the subcommittee's legislative priorities for 2010. At the top of the list is passage of the Preserve Affordable Access to Generics Act, which would prevent anticompetitive "pay-for-delay" patent settlements in which a brand-name pharmaceutical company pays a generic drug maker millions of dollars in exchange for an agreement to stop selling a generic version of the drug.
By Robert Magielnicki
In a May 24, 2010 speech to the Antitrust in Healthcare Conference, Christine A. Varney, the Chief of DOJ's Antitrust Division, emphasized the importance of antitrust enforcement in preserving vigorous competition in health insurance markets, and of encouraging innovation and efficiency in health care delivery while preserving competitive markets.
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.
By Jennifer Driscoll-Chippendale
In a Business Review Letter[1] dated April 26, 2010, the U.S. Department of Justice, Antitrust Division (hereinafter, “the Division”) stated that it would not challenge a data sharing program proposed by three health care associations located in California. From the Division’s vantage point, the program posed little risk of facilitating anticompetitive conduct; rather, the most likely effect of the program would be to increase transparency about the relative costs and utilization rates of hospitals that participated in the survey.
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