Mondaq.Com - feed of articles on Pharmaceutical, Healthcare & Life Sciences

Worldwide: Global Anticorruption Alert: DOJ Targets Pharmaceutical Industry And Individuals For FCPA Enforcement - Jones Day

Fri, 20 Nov 2009 00:00:00 GMT

Enforcement of the Foreign Corrupt Practices Act ("FCPA") continued to grow last week.

Ukraine: Moratorium On Price Increases In The Pharmaceutical Sector - CMS Cameron McKenna LLP

Fri, 20 Nov 2009 00:00:00 GMT

On 13 October 2009 the Cabinet of Ministers of Ukraine issued Resolution No. 1154, which limits both the use of particular drugs for medical purposes and increases in the price of medical products.

United States: Ambulatory Surgery Center Payment Updates - McDermott Will & Emery

Thu, 19 Nov 2009 09:45:09 GMT

CMS is increasing ASC payments by an inflation factor for the first time in more than six years.

Australia: Proposed Section 7 Declaration: Products In Capsule, Tablet Or Pill Form Are Therapeutic Goods (Medicines) - Addisons

Thu, 19 Nov 2009 09:45:09 GMT

The Therapeutic Goods Administration (“TGA”) is proposing changes to the Therapeutic Goods Act 1989 (“Act”) that would result in the form of a product being a key factor in determining whether it constitutes a medicine or a food.

United States: FDA Releases Initial Draft Guidance On Risk Evaluation And Mitigation Strategies (REMS): Seeking Input From Stakeholders - Foley Hoag LLP

Thu, 19 Nov 2009 00:00:00 GMT

The Food and Drug Administration (FDA) announced on September 30 that it has released a draft guidance [.pdf] for industry, titled "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications."

United States: FCC Seeks Comments On The Use Of Broadband To Promote Health Care Delivery And Services - McDermott Will & Emery

Thu, 19 Nov 2009 00:00:00 GMT

Comments in response to the FCC's public notice on health care issues are due December 4, 2009.

United States: The Affordable Health Care For America Act ("AHCAA") - Proskauer Rose LLP

Wed, 18 Nov 2009 00:00:00 GMT

The U.S. House of Representatives moved closer to an overhaul of the nation’s health care delivery system by passing the Affordable Health Care for America Act ("AHCAA" or the "Act") late in the evening of November 7, 2009.

United States: CMS Finalizes Requirements For Supervision Of Hospital Outpatient Services - McDermott Will & Emery

Tue, 17 Nov 2009 00:00:00 GMT

The physician supervision provisions in the OPPS/ASC Final Rule provide much needed guidance and clarification, but also will provide compliance challenges for hospitals.

United States: Health Reform Update: Focus on Prescription Drug Price Regulation - Reed Smith

Tue, 17 Nov 2009 00:00:00 GMT

While Congress continues to debate the "big picture" issues of broad-scale health care reform, pending bills in both the House of Representatives and Senate contain proposals to amend federal prescription drug price regulation programs such as the Medicaid rebate statute, the Public Health Service ("PHS") Act’s Section 340B program, and Medicare Part D.

United States: HHS Issues Interim Final Rule Conforming HIPAA Civil Money Penalties To HITECH Act Requirements - McDermott Will & Emery

Tue, 17 Nov 2009 00:00:00 GMT

The new HIPAA civil money penalties scheme substantially increases the potential penalties for HIPAA violations occurring on or after February 18, 2009.

United States: Newsletter For Leaders In The Medical Device Industry - November 2009 - Foley & Lardner

Tue, 17 Nov 2009 00:00:00 GMT

Among the myriad of proposals for health care reform are some familiar provisions that are intended to increase the transparency of relationships between device and pharmaceutical manufacturers and physicians (and some others).

United States: The H1N1 Flu: Retailers – Be Prepared - Perkins Coie LLP

Fri, 13 Nov 2009 00:00:00 GMT

The Holiday season this year carries with it not only high hopes for successful sales but the threat of widespread – and increasing – influenza outbreaks.

Canada: Pharmacapsules @ Gowlings - November 2, 2009 - Gowling Lafleur Henderson LLP

Thu, 12 Nov 2009 09:00:08 GMT

Large investors, early-stage venture capitalists, governments, corporations and industry associations are returning to the clean technology sector - cleantech.

United States: Health Care Reform: More Aggressive Fraud Enforcement And Broader Government Oversight Are On The Horizon - Fried Frank Harris Shriver & Jacobson

Fri, 06 Nov 2009 00:00:00 GMT

Much of the current debate surrounding health care reform has focused on entitlements and the mechanisms for paying for them.

United States: Is Your Wellness Program In Jeopardy For 2010? - McGuireWoods LLP

Wed, 04 Nov 2009 00:00:00 GMT

On October 7, 2009, the Departments of Labor, Health and Human Services, and Treasury jointly issued interim final regulations regarding the Title I restrictions under the Genetic Information Nondiscrimination Act of 2008 (GINA).

United States: CMS Relaxes Supervision Requirements For Hospital Outpatient Departments - Foley & Lardner

Wed, 04 Nov 2009 00:00:00 GMT

Many hospital administrators will be happy to know that the 2010 Outpatient Prospective Payment System final rule (Rule) released by CMS on October 30, 2009 addresses concerns over supervision requirements for outpatient services, in addition to covering all the usual payment changes for hospital outpatient and ambulatory surgery center payments.

United States: HITECH Act Breach Notification Rule - Barnes & Thornburg

Wed, 04 Nov 2009 00:00:00 GMT

This HIPAA Update provides a detailed description of the new breach notification requirements for HIPAA covered entities and business associates as required by interim final rule issued pursuant to the HITECH Act of 2009.

United States: Biosimilars Provision Included In House Health Care Reform Bill - The Time Has Finally Come - Foley & Lardner

Tue, 03 Nov 2009 00:00:00 GMT

On October 29, 2009, the Democratic leadership of the House of Representatives released the Affordable Health Care for America Act, H.R. 3962.

United States: Federal Circuit Reverses Medinol Fraud Standard - Ladas & Parry LLP / Ladas Domains LLC

Tue, 03 Nov 2009 00:00:00 GMT

In a highly anticipated decision, the U.S. Court of Appeals for the Federal Circuit overturned the infamous Medinol trademark procurement fraud standard previously adopted by the Trademark Trial and Appeal Board (TTAB").

United States: Warning To Employers: If Your Health Risk Assessment Violates GINA, You May Have To Tell The IRS (And Pay Excise Taxes) - Jones Day

Tue, 03 Nov 2009 00:00:00 GMT

As reported in an earlier Jones Day Commentary entitled "Open Enrollment Alert—No Reward Goes Unpunished," the Departments of Treasury, Labor, and Health and Human Services jointly issued interim final rules to implement certain provisions of the Genetic Information Nondiscrimination Act ("GINA"), including the prohibition on the collection of genetic information by group health plans and group health insurance issuers.

United States: New Excise Tax Reporting In Effect January 1, 2010 For Violations Of COBRA, HIPAA Portability, Other Group Health Plan Mandates And Final Regulations For HSA Comparable Employer Contributions - Groom Law Group

Mon, 02 Nov 2009 20:43:10 GMT

Failing to comply with various federal group health plan mandates, including COBRA and HIPAA portability, just got riskier and costlier for employers.

United States: HHS-OIG Issues Fiscal Year 2010 Work Plan - Jones Day

Mon, 02 Nov 2009 00:00:00 GMT

On October 1, 2009, the Department of Health and Human Services Office of Inspector General ("HHS-OIG") released its Work Plan for the 2010 fiscal year ("2010 Work Plan").

European Union: Paediatric Extensions – A European Initiative To Encourage Research Into Medicines For Children - Beck Greener

Fri, 30 Oct 2009 00:00:00 GMT

To sell a medicine in the European Union (EU), a marketing authorisation (MA) is required.

Turkey: Turkish Legal Update - Second Quarter 2009 - Guner Law Office

Thu, 29 Oct 2009 09:00:11 GMT

New measures for foreign currency loans and foreign currency indexed loans.

United States: GINA & HIPAA: Interim Final Rules And Privacy Proposed Rule Published - McDermott Will & Emery

Wed, 28 Oct 2009 00:00:00 GMT

The next chapter in the ongoing effort by the federal government to narrow the permissible uses of personal health information by entities engaged in the health care industry has arrived.