September 28, 2010
On September 17, 2010, the Centers for Medicare & Medicaid Services (“CMS”) and the U.S. Food and Drug Administration (“FDA”) issued a notice in the Federal Register requesting public comment on a proposed new program referred to as “parallel review” (“Comment Request”). This program would give drug and device sponsors the option of receiving an FDA premarket evaluation and a Medicare National Coverage Determination at the same time. By reducing the waiting times associated with CMS and FDA product evaluations and decreasing the likelihood that product sponsors will have to conduct separate clinical studies for each agency, CMS and FDA believe that parallel review will hasten consumer access to new innovative products and minimize the burden that FDA reviews and Medicare National Coverage Determinations impose on drug and device sponsors. These changes will not only affect parties who are interested in drug and device innovation, but providers, payers, and health care consumers as well.
September 13, 2010
by Wendy C. Goldstein, Kathleen A. Peterson, Benjamin S. Martin, and Constance A. Wilkinson
On September 3, 2010, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule withdrawing regulations governing the determination of “Average Manufacturer Price” (“AMP”), the definition of “Multiple Source Drug,” and the application of federal upper reimbursement limits (“FULs”) for Multiple Source Drugs (the “Proposed Rule”). This withdrawal would impact the applicable regulations finalized by CMS in 2007 and 2008 but would leave intact other sections of the 2007 regulations, including, for example, the “Best Price” provisions and certain “definitions” (including the definition of “bona fide service fee”). Comments may be submitted to CMS until 5:00 p.m. EDT on October 4, 2010. We recommend that organizations consider commenting on the impact of the withdrawn regulations, as well as on the open items that have not been addressed under the recent “health reform” legislation.
September 10, 2010
The Employment Equality (Age) Regulations were introduced in 2006. One of the most significant changes introduced by the regulations was that of a Default Retirement Age (“DRA”) which made it possible for an employer to fairly dismiss an employee on the ground of retirement once they reached the age of 65. So long as the employer complied with the statutory procedure, any dismissal on the ground of retirement would be fair.
This law has been under constant scrutiny since its introduction, even leading to Age Concern raising a legal action against the UK Government which was pursued all the way to the European Court of Justice. Whilst the (then Labour) Government successfully resisted this action, they did give an indication that the DRA would be reviewed in 2011. This is a nettle which has been firmly grasped by the new coalition Government who have now announced plans to phase out the DRA by 1 October 2011.
September 9, 2010
We are delighted to announce that we have been shortlisted for three categories at the prestigious Law Awards of Scotland 2010. The awards are a recognised highlight in the Scottish legal community and celebrate, in their own words, “fantastic thinking and brilliant execution”.
We are shortlisted in the following categories:
September 9, 2010
Is your board made up exclusively of corporate directors?
If so, then you have been making use of the transitional provisions under the Companies Act 2006. Under the Act all companies must have at least one natural person (otherwise, a ‘human’) as a director, although if your company was already incorporated before the new law came into effect then a grace period applies until 1 October 2010.
Failure to appoint a natural person by the end of this month could result in hefty fines being levied against both the company and the defaulting directors of up to £5,000 with the possibility of additional daily fines accruing for continuing default.
September 7, 2010
Co-authored by Christie O. Tate.
In the latest example of a significant international trade secret theft resulting in a federal criminal prosecution, chemist David Yen Lee recently pleaded guilty in federal court in Chicago to “knowingly and without authorization” possessing one or more trade secrets of his former employer Valspar Corporation (“Valspar”) with intent to convert them “to the economic benefit of someone other than the owner.” Valspar is an international company with offices in Illinois and elsewhere that manufactures and sells paint and coating products in the United States and internationally. Lee worked for Valspar as a Technical Director from approximately 2006 until March 2009, when he departed for Nippon Paint (“Nippon”), a Valspar competitor.
September 3, 2010
If you are in the New York City area and would like to strengthen your leadership skills and network with other women professionals, the Athena Leadership Lab at Barnard College (Columbia University’s Liberal Arts College for Women), in Manhattan is offering hands-on courses designed to “teach women the practical elements of leadership – from the art of negotiation to effective public speaking, from financial fluency to management savvy.” You don’t need to be a current or past student of Barnard College to enroll.