Archives: Regulatory Developments

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Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist. The FDA has announced a two-day public hearing on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  In-person … Continue Reading

FDA Mandates Black Box Warnings For Opioids And Benzodiazepines

The Food and Drug Administration (FDA) recently decided to require so-called “black box warnings” on nearly 400 products, warning of the risks of combining certain opioid medications and central nervous system depressants called benzodiazepines. Opioids are a class of powerful, pain-reducing medications that include oxycodone, fentanyl, and morphine.  Certain prescription cough suppressants also contain opioids.  … Continue Reading

Please Join Us For A Reed Smith Webinar On 3D Printing – Will Regulatory Pathways and Reimbursement Change?

The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “Think Differently. 3D Printing – Will Regulatory Pathways and Reimbursement Change?” on July 21 , 2016 at 12:00 p.m. ET. Reed Smith presenters Gail Daubert, Celeste Letourneau and Kevin Madagan will be discussing the increasing popularity of 3D printing and … Continue Reading

HHS Agenda Signals FDA’s Intent to Issue Proposed DSCSA Rules in December 2016

FDA intends to issue long-awaited proposed regulations governing the licensing of prescription drug wholesale distributors and third-party logistics providers (“3PLs”) this December, according to the updated 2016 HHS regulatory agenda.  Under the Drug Supply Chain Security Act (“DSCSA”), FDA was required to issue these regulations no later than two years following the law’s November 2013 … Continue Reading

New VA Policy to Have Immediate Impact on Many Pharmaceutical Manufacturers, Suppliers

In a significant policy reversal that will affect many pharmaceutical manufacturers and suppliers – and that will require immediate action by many pharmaceutical manufacturers – the Department of Veterans Affairs is now requiring that all covered drugs under the Veterans Health Care Act be offered on Federal Supply Schedule (FSS) contracts, regardless of whether they … Continue Reading

Navigating the Regulatory Issues of 3D Printing

The increasing popularity of 3D printing is changing the future of health care far more dramatically than we would have ever imagined. Although we have blogged about 3D printing, and the Reed Smith white paper, “3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles” addressed regulatory issues for medical devices and … Continue Reading

A Proposed End to “Amarin Pharm v. FDA” has FDA Agreeing to Abide by District Court’s Order

We have been closely following Amarin Pharm, Inc. v. FDA with respect to the preliminary injunction granted by the Southern District of New York that prohibited the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa. We’ve also been following the similar Pacira Pharm., Inc. v. FDA case, which … Continue Reading

FDA Gauges Coverage Organizations’ Interest in Connecting with Device Sponsors to Discuss Evidence Needs During Clearance Process

The FDA published a notice on February 24, 2016 requesting whether organizations (e.g. insurers, health technology assessment organizations) that evaluate clinical evidence used to support private payer medical device coverage decisions are interested in providing input to medical device developers on clinical trial design or other evidence-gathering needed to support positive coverage decisions.  If coverage … Continue Reading

French Bribery Act Would Be Anti-Corruption Revolution

We’ve covered the French Sunshine Act, which requires French pharmaceutical companies to disclose their links to healthcare providers, extensively over the past few years and most recently here. France on the whole, however, has been lagging behind many other countries when it comes to anti-corruption laws. It looks like that’s about to change in ways … Continue Reading

UPDATE: Pacira Pharmaceutical Inc. v. FDA Lawsuit Settled

The Pacira Pharmaceutical Inc. v. FDA lawsuit has been a frequent topic of discussion on the blog, and now, in breaking news, the case has been settled.  Pacira will be receiving essentially everything it wanted in a “favorable resolution,” and the FDA is formally withdrawing its warning letter that attempted a retroactive reduction in the … Continue Reading

Stark Law Regulations: More Flexible in 2016

Recently, the Centers for Medicare & Medicaid Services (CMS) released final regulations under the physician self-referral law known as the Stark Law. We previously discussed the topic here, on our Health Industry Washington Watch blog here and in a  American Health Lawyers Association Weekly article  “CMS Publishes Final Stark Law Regulations” written by Karl Thallner and Nicole … Continue Reading

Effective Today: New Federal Rules Of Civil Procedure Regarding Discovery And Electronically Stored Information

​In changes that have been five years in the making, amendments to the Federal Rules of Civil Procedure go into effect today, December 1, 2015. Two major amendments have received much attention and analysis.  The first is the addition of an express proportionality requirement to Rule 26(b)(1) regarding the Scope of Discovery, and the second … Continue Reading

Final Stark Law Regulations Published by CMS

As previously discussed here and on our Health Industry Washington Watch blog here the Centers for Medicare & Medicaid Services (CMS) has released final regulations under the physician self-referral law known as the Stark Law. The provisions of the final rule are effective on January 1, 2016, except for certain changes on calculating ownership percentages for … Continue Reading

Upcoming Reed Smith Webinar on Cross-Border E-Discovery & New Ruling Regarding the US-EU Safe Harbor Framework

The Reed Smith Life Sciences Health Industry (LSHI) Group will be hosting an upcoming webinar “Cross-Border E-Discovery & New Ruling Regarding the US-EU Safe Harbor Framework” on November 24, 2015 from 9:00 a.m. PT, 12:00 p.m. ET, 5:00 p.m. GMT until 10:00 a.m. 1:00 p.m. ET, 6:00 p.m. GMT. Reed Smith presenters including London based … Continue Reading

Updates Regarding the Pacira Pharmaceutical Inc. v. FDA Lawsuit Regarding First Amendment and Off-Label Promotion Issues

As readers of this blog know, following Amarin’s success in obtaining a preliminary injunction limiting FDA enforcement action against it for truthful, non-misleading off-label promotion of its prescription drug Vascepa, Pacira Pharmaceuticals filed a similar lawsuit regarding off-label promotion of its prescription drug Exparel. While we await the FDA’s response to Pacira’s motion for preliminary … Continue Reading

Upcoming Reed Smith Webinar on European Union’s Safe Harbor Ruling

As previously discussed here and here the Court of Justice of the European Union (CJEU) handed down its judgment in Maximillian Schrems v Data Protection Commissioner (Case C-362/14)  that the Safe Harbor Decision no longer provides adequate protection for data transferred between the EU and the U.S. In light of this ruling, Reed Smith will be … Continue Reading

OCR Creates Online Portal for HIPAA Compliance Questions

In a recent Law360 article (login required), Partner Brad Rostolsky, addressed the establishment of an online portal to receive questions from developers of mobile medical apps about compliance with the Health Insurance Portability and Accountability Act. “Where health information is flowing pretty freely on mobile devices, it’s incredibly important for everyone involved to make the … Continue Reading

Court Justice of the European Union Rules Safe Harbor Decision Invalid

In a decision with significant potential ramifications for flows of personal data from the European Union to the United States, the Court of Justice of the European Union (CJEU) handed down its judgment in Maximillian Schrems v Data Protection Commissioner (Case C-362/14) that the Safe Harbor Decision no longer provides adequate protection for data transferred between … Continue Reading

Change Coming to FDA’s “Intended Use” Regulations?

Over at the Drug And Device Law Blog, our colleagues call attention to proposed changes to the “intended use” regulations for prescription drugs and devices, 21 C.F.R. §201.128 and 21 C.F.R. §804.1, somewhat hidden within a proposed rule regarding tobacco published in the Federal Register on September 25, 2015. As the FDA explained, the changes … Continue Reading

Proposed Rule Issued by CMS Modifies Requirements for LTC Facilities Participating in Medicare and Medicaid Programs

As previously discussed here on our Health Industry Washington Watch blog, CMS is publishing a notice extending by 30 days the comment period for its July 16, 2015 proposed rule entitled “Reform of Requirements for Long-Term Care Facilities.” The revisions of the “Proposed Rule” indicate an increased cost of $729 million in the first year … Continue Reading

Cure of Security Rule Violations Following Breach of EPHI Cannot Save Covered Entities from $750,000 Settlement; Non-Breach Related Security Complaint Leads to $218,000 HIPAA Settlement

More than three years after the Cancer Care Group, P.C. (“CCG”) notified the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) of a breach of unsecured electronic protected health information (“ePHI”), the radiation oncology private practice settled and implemented a corrective action plan (“CAP”) with OCR for $750,000. This settlement … Continue Reading

First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA

The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved label indications.  The Amarin Pharm v. FDA litigation has garnered a good deal of attention, and after Amarin and the FDA … Continue Reading

Federal Departments and Agencies Release Proposed Rule to Modernize Regulations Under Common Rule

As discussed on our Health Industry Washington Watch blog here, on September 2, 2015, the Department of Health and Human Services (HHS),  along with fifteen other federal departments and agencies, released a proposed rule to modernize regulations governing human research subjects under the Common Rule. Currently the Common Rule applies to all research involving human … Continue Reading
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