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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

FCC Sheds New Light on TCPA’s Exemption for Healthcare-Related Calls

As we have previously reported, the Federal Communications Commission (“FCC”) issued a Declaratory Ruling and Order (“Order”) on July 10, 2015, clarifying several sections of the Telephone Consumer Protection Act (“TCPA”) and its implementing regulations.  One important clarification addressed a petition filed by the American Association of Healthcare Administrative Management (“AAHAM”) in October 2014 regarding … Continue Reading

340B Drug Pricing Program Omnibus Guidance Notice Published by Health Services Resources Administration

On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. Although many aspects of the Notice reiterate previous HRSA guidance, several elements will generate significant debate among program stakeholders regarding the scope of the 340B program.  In addition, the Notice presages a … Continue Reading

First Opinion Issued on ACA “60-Day Overpayment Rule” in a FCA Case

In a case dating back several years, the first judicial opinion interpreting the Affordable Care Act’s “60-Day Overpayment Rule” in a False Claims Act case was recently issued by the Southern District of New York. In Kane v. Healthfirst, Inc., et al., the court found in favor of the DOJ, denying the defendant hospitals’ motion … Continue Reading

What Comes Next In Amarin Pharm v. FDA?

The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa—understandably has been big news, analyzed here  and  elsewhere. Some are asking whether the FDA will pursue appellate review of the decision.  An indication about … Continue Reading

Amarin Obtains Preliminary Injunction Against FDA Regarding Off-Label and First Amendment Issues

In our prior posts about Amarin Pharma, Inc. v. FDA, we wondered what the Southern District of New York would make of Amarin’s request for an order prohibiting the FDA from taking enforcement actions against it over speech regarding “off-label” uses of its prescription drug, Vascepa.  Although Vascepa is regulated as a drug, equivalent products … Continue Reading

CMS Releases Proposed Stark Law Regulations

As previously discussed on our Health Industry Washington Watch blog, the Centers for Medicare & Medicaid Services (CMS) has proposed regulations “to reduce burden and to facilitate compliance” under the physician self-referral law known as the Stark Law. However, even with changes, the regulations will remain highly complex, with major implications for health care providers … Continue Reading

FCC Finally Issues Omnibus Ruling on TCPA Litigation and Compliance

Ambiguities in the Telephone Consumer Protection Act (TCPA) have been a recent topic of interest. This past week, the FCC finally released the long awaited TCPA Omnibus Declaratory Ruling and Order resolving 21 petitions on many issues associated with the enforcement and interpretation of the Act. As the authors note in yesterday’s Reed Smith Client Alert, … Continue Reading

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior  posts  looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  We provided links to amicus briefs by the Pharmaceutical Research and Manufacturers of America and the Washington … Continue Reading

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  As we noted, on June 8, 2015, … Continue Reading

FCC Ruling Clarifies Ambiguities in the TCPA

For years  industry groups have been petitioning the Federal Communications Commission (FCC) to clarify ambiguities in the Telephone Consumer Protection Act (TCPA), which make it difficult for businesses to comply and leave them vulnerable to litigation. Finally, on June 18, 2015, the FCC responded. As discussed in a Client Alert by Reed Smith attorneys Judith … Continue Reading
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