News & Analysis as of

Prescription Drugs

Canada introduces reporting mechanism for dangerous counterfeit goods, helping rights holders protect their brands at the border

by Smart & Biggar on

Recently, the Canada Border Services Agency (CBSA), the federal organization responsible for policing Canada’s borders, issued a Customs Notice (CN17-27) to advise the public and rights holders that its 24/7 “Border Watch”...more

Awful Missouri Venue and Warnings Opinion Affirmed—But Maybe Some Hope

by Reed Smith on

Hope springs eternal. At least that is what the optimists say, and while we would like to see the bright side of the Missouri Supreme Court’s split opinion on venue in Barron v. Abbott Laboratories, Inc., No. SC 96151, 2017...more

Pfizer and Flynn Pharma fined €101 million for charging the UK health service excessive prices for Phenytoin sodium capsules, an...

by Dechert LLP on

The UK Competition and Markets Authority (“CMA”) recently published its infringement decision of 7 December 2016 that imposed a fine on Pfizer and Flynn Pharma (“Flynn”) for abusing their respective dominant positions by...more

FDA Announces Biosimilar User Fee Act Rates for FY2018

by Goodwin on

Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2018 federal fiscal year, which runs from October 2017 through September 2018. The FDA determined these rates pursuant to the Food and Drug...more

AGG Food and Drug Newsletter - September 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

by Arnall Golden Gregory LLP on

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing...more

October 15th Deadline: Medicare Part D Notice Of Creditable (Or Non-Creditable) Coverage

by Fraser Trebilcock on

UPDATED: September 19, 2017 – Employers who offer prescription coverage to any Medicare Part D eligible employees (whether or not retired), or Medicare Part D Medicare-eligible spouses or dependents, you must provide those...more

Health Alert (Australia) 18 September 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 6 September 2017 - Finding of inquest into death of Phillip William Michell - Phillip William Michell died on 11 July 2015 at the...more

Blog: California Governor Considers Drug Price Reporting Bill and Ban on Discounts and Rebates for Branded Pharmaceutical Products

by Cooley LLP on

The California State Legislature sent two new pharmaceutical pricing measures, S.B. 17 and A.B. 265, to Governor Jerry Brown on September 13th. S.B. 17 would impose new reporting requirements on pharmaceutical manufacturers...more

Worried About Fake News? You Should Really Worry About Fake Drugs

While the concept of “fake news” continues to trigger Twitter followers and grab headlines, the trade in counterfeit drugs is a worldwide problem of significant scale. This article discusses the problem and talks about some...more

Citing the Opioid Abuse Epidemic, New Jersey Proposes Far-Reaching Restrictions on Pharma-Prescriber Interactions

by Stinson Leonard Street on

In an effort to curtail the opioid abuse epidemic, New Jersey Governor Chris Christie proposed a new rule on August 31, 2017 that would make New Jersey the latest state to adopt "gift ban" type restrictions on interactions...more

When Plaintiff Conduct Matters

by Reed Smith on

We previously addressed the in pari delicto doctrine, whereby a plaintiff injured in the course of his or her criminal conduct cannot recover for those injuries. We specifically examined this doctrine’s most common...more

A road map to Life Sciences M&A in Russia

by Hogan Lovells on

U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more

New Jersey Joins Wave of States Proposing New Rules for Drug Marketing and HCP Interactions

by Hogan Lovells on

Drug manufacturers are once again facing new state limits on marketing and interactions with healthcare providers. Manufacturers should review the new laws and regulations carefully, consider how they might engage with the...more

OIG Signs Up for Customer Loyalty Program

by BakerHostetler on

In Advisory Opinion 17-05, posted by the U.S. Department of Health and Human Services Office of Inspector General (OIG) on September 7, 2017, the OIG approved a pharmacy’s customer loyalty/discount program (Benefit Program)....more

FDA Clarifies Trading Partners Under the DSCSA

by Reed Smith on

The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with...more

OIG issues Advisory Opinion on a Retail Pharmacy’s Paid Membership Program Which Includes Federal Health Care Program...

by Dorsey & Whitney LLP on

On September 7, 2017, the OIG posted an advisory opinion regarding a retail pharmacy chain’s proposal to extend to federal health care program beneficiaries the option to participate in a paid membership program that includes...more

The Growing Number of Civil, Criminal, and Legislative Investigations of Insys Therapeutics, Inc. by Federal, State, and...

by Arnall Golden Gregory LLP on

On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization....more

FDA Commissioner Touts Seamless Clinical Trails, Use of Modeling and Simulation As Ways to Lower Drug Costs

In remarks at the Regulatory Affairs Professionals Society’s (RAPS) 2017 Regulatory Convergence Conference yesterday, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., spent considerable...more

FDA re-approves Mylotarg® antibody-drug conjugate seven years after it had been withdrawn from the market

by Knobbe Martens on

Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S. Food and Drug Administration has re-approved Mylotarg® product....more

A Client's Guide to FDA Inspections

A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to...more

Medical Marijuana 104: Responsibilities of Health Insurers

by Farrell Fritz, P.C. on

It will come as no surprise that patients who are thinking about getting certified for medical marijuana use have a number of questions relating to the cost of obtaining medical marijuana products....more

Health Alert (Australia) 11 September 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 4 September 2017 - Eve Hemp Pty Limited v Secretary to the Department of Health [2017] FCA 1051 - ADMINISTRATIVE LAW – judicial review –...more

State Scrutiny of Payments to Providers Growing in Response to Opioid Crisis

by Dorsey & Whitney LLP on

Several states have proposed and enacted new laws to address the opioid crisis, including laws that focus on reducing financial incentives that drug manufacturers can give to providers. Most recently, New Jersey Governor...more

Coming soon from FDA? Streamlined safety information in prescription drug television ads

by DLA Piper on

Most people are by now familiar with prescription drug TV ads that provide lengthy (and often confusing) laundry-list descriptions of numerous potential safety risks (seemingly regardless of the severity or likelihood of the...more

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