Tag Archives: Pharmaceuticals

Supreme Court Decision on Reverse Payments has Significant Implications for Pharmaceutical Manufacturers

Reed Smith’s Global Regulatory Enforcement Law Blog recently featured a detailed analysis of the Supreme Court’s decision in FTC v. Actavis, where the court ruled five-to-three that reverse payments, also called pay-for-delay settlements, can violate antitrust laws and are subject to antitrust review under the rule-of-reason. As reverse payments are commonly used by branded drug … Continue Reading

Massachusetts Releases Final Regulations, Restores Annual “Sunshine” Reporting Requirement for Drug/Device Manufacturers

On Wednesday, November 21, 2012, Massachusetts' Public Health Council ("Council") approved amendments to the State's Marketing Code of Conduct, which restricts certain gifts and payments by pharmaceutical and medical device manufacturers to Massachusetts health care practitioners ("HCPs") and requires disclosure of payments and transfers of value to HCPs. The final regulations, effective as of December 7, 2012, primarily adopt the emergency regulations issued by the State in September but make a few substantive changes.… Continue Reading

China Life Sciences and Health Industry Client Briefing – October 2012 (November 16, 2012)

This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Mao Rong, Katherine Yang, May Wong, Amy Yin and Gordon B. Schatz. Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ … Continue Reading

Massachusetts Signals Potential Elimination of HCP Payment Reporting Requirement Through Emergency Regulatory Amendments

On September 19, 2012, the Massachusetts Public Health Council approved emergency amendments to the State's Marketing Code of Conduct regulations, 105 CMR 970.000, which restrict certain gifts and payments by pharmaceutical and medical device manufacturers to Massachusetts health care practitioners ("HCPs") and require disclosure of payments and transfers of value to HCPs. The regulations, effective as of September 19, 2012, follow amendments to the underlying statute, Massachusetts General Laws, Chapter 111N, signed into law in July by Governor Deval Patrick as part of the FY2013 State Budget.… Continue Reading

China Life Sciences and Health Industry Client Briefing – August 2012 (September 18, 2012)

This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Mao Rong, Katherine Yang, May Wong, Amy Yin and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health … Continue Reading

China Life Sciences and Health Industry Client Briefing – July 2012 (August 8, 2012)

This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Katherine Yang, May Wong and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries Some important … Continue Reading

Life Sciences Health Industry China Briefing – June 2012 (July 20, 2012)

Recent posts on www.lifescienceslegalupdate.com include: "Supreme Court Rules That Juries - Not Judges - Must Determine Facts Supporting Large Criminal Fines" The Reed Smith Global Regulatory Enforcement Law blog has an interesting post about a recent U.S. Supreme Court ruling that protects the Sixth Amendment rights of defendants in high-stakes criminal cases. In Southern Union Co. v. United States, the Court ruled that any fact supporting a "substantial" criminal fine must be found by a jury applying the "beyond a reasonable doubt" standard. In this post, Efrem M. Grail and Kyle R. Bahr explain the opinion and discuss the wide impact it will have on criminal actions, from investigation to sentencing. View the entire entry: https://www.lifescienceslegalupdate.com/2012/07/articles/health-care/supreme-court-rules-that-juries-not-judges-must-determine-facts-supporting-large-criminal-fines/ ... and "Life Sciences Health Industry China Briefing - June 2012 (July 20, 2012)" Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.… Continue Reading

Life Sciences Health Industry China Briefing – May 2012 (June 14, 2012)

This post was written by John Tan, Jay J. Yan, Mao Rong, Katherine Yang, and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. Some important developments during May include: Introduction … Continue Reading

Life Sciences Health Industry China Briefing – March 2012 (April 13, 2012)

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.  Some developments during March include: American Medical Device Maker Accused of Bribery to Doctors in China and other Countries Qiagen Inks HPV Screening Deal with … Continue Reading

Life Sciences Health Industry China Briefing – February 2012 (March 13, 2012)

This post was written by Jay J. Yan, Mao Rong, Zack Dong, Katherine Yang, Joyce Sun, Sara Lai and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. Some important developments … Continue Reading

Life Sciences Health Industry China Briefing – January 2012 (February 13, 2012)

Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. Some important developments during January include: - Outline of China's Nursing Development Plan from 2011 to 2015 - Promulgation of Eight Recommended Medical Product Industry Standards - Strengthening Implementation of 2010 GMP Amendment - Circulation of the 12th Five-Year Plan for Medical Device Technology Industry… Continue Reading

Latest Post-Levine Case Holds That Conflict Preemption Bars Plaintiff’s Failure-To-Warn Claims

One of the strongest defenses against product liability claims, including a failure to warn claim, is federal preemption. For cases against prescription drug manufacturers, defense lawyers have specifically asserted conflict preemption to argue that failure to warn claims are preempted by the FDA’s regulations governing the content of labels for prescription drugs. Essentially, defense lawyers … Continue Reading

Food and Drug Law Institute’s Upcoming US-China Food and Drug Law Conference in Beijing, China

The Food and Drug Law Institute (FDLI) has an interesting upcoming conference on June 13-14 in Beijing, China that will address current legal, regulatory and economic issues regarding food, cosmetics, dietary supplements, pharmaceuticals and medical devices in China and the United States. Speakers are top government officials and internationally renowned experts who will discuss the issues in both countries.… Continue Reading

Upcoming Hearing on Draft Dingell/Waxman Drug Safety Legislation

On September 30, the House Energy and Commerce Committee is holding a hearing on draft drug safety legislation (per http://energycommerce.house.gov/index.php?option=com_jcalpro&Itemid=54&extmode=view&extid=230&date=2010-09-30, witness list not yet available). The legislation, which was drafted by Reps. John Dingell, Henry Waxman, Frank Pallone, and Bart Stupak, requires parity between foreign and domestic drug facility inspections, increases the number of pre-approval drug inspections, prohibits the entry of drugs into the United States lacking documentation of safety, requires manufacturers to ensure the safety of their supply chain, and grants FDA authority to mandate recalls of unsafe drugs. For background information on the draft legislation (including the text), see http://energycommerce.house.gov/index.php?option=com_content&view=article&id=2123:waxman-dingell-pallone-a-stupak-open-discussion-on-potentially-historic-changes-in-drug-safety-laws&catid=122:media-advisories&Itemid=55&layout=default&date=2010-10-01.… Continue Reading

FDLI Publishes New Guide to International Prescription Product Recalls

Recent events highlight the importance of having a plan for product recalls. The Food and Drug Law Institute's recent monograph entitled, "International Prescription Product Recalls: A Practical Guide, Volume 1, Number 4," provides comprehensive guidance and practical recommendations on dealing with recalls internationally as well as a checklist and valuable "dos and don'ts" for manufacturers facing product recalls. Written by Reed Smith partners James M. Wood and Areta L. Kupchyk, the publication is available for download by series and individual issue subscribers. For more information or to order, see www.fdli.org.… Continue Reading

FDA Discusses Social Media Advertising Regulation for the Life Sciences Industry

On November 12 and 13, 2009, the FDA hosted public hearings to vet the potential need for regulation of prescription pharmaceutical and medical device marketing on social media outlets such as YouTube, Wikipedia, Facebook, and Twitter. The FDA specifically sought input on these five questions: (1) For what online communications are manufacturers, packers or distributors accountable? (2) How can manufacturers, packers, or distributors fulfill regulatory requirements in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications? (3) What parameters should apply to the posting of corrective information on Web sites controlled by third parties? (4) When is the use of links appropriate? and (5) Questions specific to Internet adverse event reporting...… Continue Reading

Third Circuit Holds That MDL Judges Can’t Reverse Pre-Transfer Orders Absent Extraordinary Circumstances

In a precedential decision issued Thursday, In Re: Pharmacy Benefit Managers Antitrust Litigation (MDL 1782), the U.S. Court of Appeals for the Third Circuit reinstated a district court order compelling arbitration of antitrust claims, an order which another district court judge vacated after the case was transferred to a federal Multi-District Litigation (MDL)s, Based on the law of the case doctrine, the Court of Appeals held that MDL judges may not overturn an order of the transferor court absent a finding of extraordinary circumstances - a conclusion that has broad ramifications for MDL proceedings in general...… Continue Reading

New Developments in Nanotechnology

A recent study suggests that exposure to nanoparticles may have caused the death of two female workers and the illnesses of five others in China. Life science health industry companies that manufacture, integrate, sell or buy products that contain nanomaterials may want to monitor reaction to this report, which may garner attention from media outlets, scientists, regulators and the plaintiffs' bar. For a full discussion of these issues, review the full Client Alert written by Reed Smith attorneys Antony Klapper, Jesse Ash and David Wagner.… Continue Reading

The New Consumer Product Safety Improvements Act — Implications for Pharmaceutical Manufacturers

This post was written by Stephen P. Murphy. On Aug. 14, 2008, the President signed the Consumer Product Safety Improvements Act (the Act) into law. By an unfortunate and possibly unintended consequence of poor drafting by the Congress, all of the statutes enforced by the U.S. Consumer Products Safety Commission were brought within the coverage … Continue Reading

EPA Moves Towards Possible Regulation of the Disposal of Unused Pharmaceuticals in Sanitary Sewer Systems

This post was written by Louis A. Naugle and Mark A. Mustian. On Aug. 12, 2008, EPA announced its intention to submit an Information Collection Request (“ICR”) to the Office of Management and Budget, for collection of information from the Health Services Industry. 73 FR 46903 This ICR is the first step by EPA toward … Continue Reading
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