News & Analysis as of

Prescription Drugs

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Appeal for Legislative Action to Address REMS Concerns

by Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting, these two...more

Product Liability Update: April 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Prescription Drug Case Holds “Learned Intermediary” Rule Requiring Warnings Only To Prescribing Physician Applied Even Though Patient and Caregiver Were Physicians, But Experts’ Affidavits of...more

Prescribing Controlled Substances Without an In-Person Exam: The Practice of Telemedicine Under the Ryan Haight Act

by Foley & Lardner LLP on

Editor’s Note: This article is the second in a series addressing telemedicine prescribing and controlled substances, designed to give some much needed practical guidance and orientation to established healthcare providers,...more

First Circuit Affirms Dismissal Of Securities Fraud Claims For Failure To Adequately Plead Scienter

by Shearman & Sterling LLP on

On April 7, 2017, the United States Court of Appeals for the First Circuit affirmed the dismissal of a putative securities fraud class action against the biopharmaceutical developer Zafgen, Inc. (“Zafgen”) and its CEO. ...more

Five Trends in False Claims Act Enforcement: Take Two

In July 2015, we posted about the N.Y. Attorney General’s False Claims Act (FCA) settlements with Trinity HomeCare and its related entities, and how the case provided insight into the future of FCA enforcement. We identified...more

Cures Corner: FDA Launches Regenerative Medicine Advanced Therapy Designation Program

by Jones Day on

In late January 2017, FDA took the first steps to implement certain provisions of the 21st Century Cures Act ("Act"), signed into law on December 13, 2016, by launching a new designation program for regenerative medicine...more

EMA’s initiative of expanding the use of early background summaries

by Hogan Lovells on

In an effort to help assessors evaluate initial marketing authorization applications, the European Medicines Agency (EMA) has taken the initiative to extend the use of “early background summaries”....more

EU-U.S. Agreement for Mutual Recognition of GMP Inspections Entered Into Force

by Jones Day on

On March 4, 2017, the "Decision No 1/2017 of March 1, 2017, of the Joint Committee established under Article 14 of the Agreement on Mutual Recognition between the European Community and the United States of America, amending...more

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

Legislation Tracker: Improving Access to Affordable Prescription Drugs Act

by Goodwin on

On March 29, Senator Al Franken and fifteen co-sponsoring Senate Democrats introduced a bill called the “Improving Access to Affordable Prescription Drugs Act” (S. 771). A companion bill (H. 1776) with the same title was...more

Year in Review: Some Positive Developments for Pharmaceutical Class Actions in Canada

The end of 2016 brought with it some good news for the defence in respect of pharmaceutical class actions, including a successful defence verdict in the first pharmaceutical product liability common issues trial in Canada. In...more

Health Alert (Australia) April 10, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 5 April 2017 - Reckitt Benckiser (Australia) Pty Ltd v Australian Competition and Consumer Commission [2017] HCASL 86 - The High...more

Disputing Inaccurate Reports Under the Physician Payment Sunshine Act

by Ruder Ware on

The Affordable Care Act added the Physician Payment Sunshine Act (Sunshine Act) as section 1128G to the Social Security Act. The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical...more

Telemedicine Prescribing and Controlled Substances Laws

by Foley & Lardner LLP on

Editor’s Note: This article is the first of a series addressing telemedicine prescribing and controlled substances, designed to give some much needed practical guidance and orientation to established health care providers,...more

[Webinar] Investment Decisions for Investors and Entrepreneurs Considering 505(b)(2) Drug Applications: How to Make Sure Your...

by Robins Kaplan LLP on

Wednesday, April 19, 2017, 1:00 P.M. CST -- Are you an investor or entrepreneur considering 505(b)(2) drug applications? Join Jake Holdreith, Robins Kaplan, and Ken Phelps, Camargo Pharmaceutical Services for a complimentary...more

DEA awards Schedule II classification to synthetic THC drug

by Thompson Coburn LLP on

On March 23, 2017, the DEA announced it has scheduled the newly approved synthetic THC-containing drug, Syndros, as a Class II substance. This announcement comes as a surprise to some for a number of reasons, including that...more

Purchase of expensive drugs from outside the EU: did AIFA open the Pandora’s box?

by Hogan Lovells on

By Ministerial Circular of 23 March 2017, AIFA clarified the conditions under which unauthorized medicinal products may be purchased abroad further to the procedure laid down by the Ministerial Decree of 11 February 1997....more

News From the Vermont Statehouse - An Analysis from DRM’s Government & Public Affairs Team - March 2017 #3

Paid Family Leave Could Be Costly - The House Committee on Ways and Means took up H.196, the Paid Family Leave bill this week after it passed out of the House Committee on General, Housing and Military Affairs over...more

How Much Can I Prescribe? Delaware and New Jersey Enact Stricter Opiate Prescribing Laws

by Fox Rothschild LLP on

Beginning April 1, 2017, the regulations regarding opiate prescribing will be changing. A Delaware healthcare practitioner will only be able to prescribe initial opioid prescriptions for acute pain episodes for up to seven...more

A Judicial Reinterpretation of the Brazilian Constitution’s Right to Health Care

by Ropes & Gray LLP on

In recent years, there has been a spike in right-to-health litigation in Brazil wherein citizens seek court orders mandating that certain medications be dispensed through the public health system (Sistema Único de...more

Roche's Subcutaneous Rituximab Gets Unanimous Recommendation from FDA Advisory Committee

by Goodwin on

In a press release, Roche announced today that FDA’s Oncologic Drug Advisory Committee has voted unanimously in favor of a subcutaneous injection of rituximab for the treatment of certain blood cancers, including previously...more

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