Pharmaceutical Industry Healthcare

News & Analysis as of

UK MHRA to develop quality standards for biological medicines

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines....more

Obama Administration Issues Changes to Iran Sanctions Regulations That Benefit Exporters of Medicine, Medical Devices and...

On December 23, 2016, the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”) published a number of changes to the Iranian Transactions and Sanctions Regulations (“ITSR,” 31 C.F.R. Part 560) that expanded the...more

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ? Intent, But Knowledge Certainly Can Be One Element in Establishing the...

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

EMA hosts workshop on adaptive pathways

On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach. The aim...more

EMA on optimising the development of advanced therapies

On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory conference concerning the optimisation of the development of...more

UK MHRA publishes “top tips” for manufacturing authorisation applicants

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on common mistakes made by applicants, to help reduce...more

HRSA Releases Ceiling Price and CMP Final Rule

The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more

21st Century Cures: Food and Drug Administration (FDA) Drug Provisions

The 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment and facilitating innovation review and...more

On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types....more

Healthcare Law Update: December 2016

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more

U.S. Department of Justice Recovered More Than $4.7 Billion From Civil False Claims Act Cases in 2016

On December 14, 2016 the United States Department of Justice made its annual announcement of the amount of money recovered in civil False Claims Act settlements and judgments in Fiscal Year 2016. ...more

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

New Law Permits Stand-Alone Health Reimbursement Arrangements (HRAs) For Small Employers

On December 13, 2016 President Obama signed into law the 21st Century Cures Act. The law had been approved with bipartisan support in the House by a vote of 392 to 26 and in the Senate by a vote of 94 to 5. The law addresses...more

Senate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA?

On Wednesday, the U.S. Senate overwhelmingly passed the 21st Century Cures Act (the “Act”) by a vote of 94 to 5. Spearheaded by Michigan Representative Frank Upton, the bill now heads to President Obama who has promised to...more

House Passes 21st Century Cures Act

On November 30, 2016, the House of Representatives passed the 21st Century Cures Act, a bill intended to modernize health care delivery and speed up and improve medical research and innovations by removing bureaucratic...more

Repealing and Replacing the ACA: Five Developments Likely to Occur in the Years Ahead

On the back of the 2016 United States presidential election results, the health care industry ponders how a Republican president and Congress will transform the business environment. The health care industry has a number of...more

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

Second Circuit Affirms Preliminary Injunction of "Identical" Gray Goods

Earlier this month in Abbott Laboratories v. Adelphia Supply USA et al, the Second Circuit affirmed a district court's grant of a preliminary injunction halting the alleged sale of gray-good diabetes test strips made by...more

Recent Developments around Pharmaceutical Drug Spending in Massachusetts

Throughout the fall, policy makers in Massachusetts have sharpened their focus on the rise of pharmaceutical drug prices and their role in the growth of overall health care spending in the Commonwealth. Both the Center for...more

Three Former Warner Chilcott District Managers Prosecuted for HIPAA Violations

The United States Attorney’s Office for the District of Massachusetts recently announced that three former district managers of the pharmaceutical firm Warner Chilcott have been sentenced for violating the Health Insurance...more

A Trump Presidency: Potential Impact on Employee Benefits Law and Policy

For many months, we have been speculating about how the results of the 2016 presidential election would impact employee benefits policy going forward. Now that Donald Trump has won the election and Republicans have secured a...more

Accepting Anonymous Tips: FDA's Website for Reporting Medical Device Regulatory Misconduct

For device manufacturers and sellers, the website represents another source of information to monitor for possible challenges ahead. Unidentified tipsters — from disgruntled former employees to plaintiffs’ attorneys —...more

New Clinical Trial Rule Alters Reporting Requirements

New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health...more

FDA Launches New Webpage to Report Regulatory Misconduct

Earlier this week, the FDA launched a new webpage to simplify the process of reporting violations of the law by medical device manufacturers and individuals marketing medical devices. Unlike the MedWatch system for reporting...more

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