Michael H. Hinckle

Michael H. Hinckle

K&L Gates LLP

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340B Update: HRSA Proposes Penalties for Drug Manufacturers that Overcharge Covered Entities

On June 16, 2015, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released proposed rules on civil monetary penalties and drug ceiling prices under the...more

6/24/2015 - Affordable Care Act Civil Monetary Penalty Comment Period Drug Pricing Healthcare HHS HRSA Orphan Drugs Pharmaceutical Manufacturers Prescription Drugs Proposed Regulation Section 340B

FDA Proposes New Expansive Animal Drug Antimicrobial Reporting Regulations

On May 20, 2015, the Food and Drug Administration (“FDA”) proposed new regulations implementing the annual reporting requirements that were originally enacted by Congress in section 105 of the Animal Drug User Fee Amendments...more

5/26/2015 - Animal Drugs FDA Proposed Regulation Reporting Requirements

Makena Drug Compounding Lawsuit Against FDA Gets New Life

On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more

1/20/2014 - DQSA Drug Compounding Drug Safety Enforcement FDA FDCA Generic Drugs Pharmaceutical Pharmacies Prescription Drugs

Congress Passes New Drug Compounding Law Increasing Federal Oversight Over Compounding Pharmacies

In the fall of 2012, a meningitis outbreak sickened more than 750 people, killing 64 people and leaving many others with pain and nerve damage. The meningitis was traced back to tainted injectable steroids manufactured at a...more

11/27/2013 - Drug Compounding FDA FDCA Fungal Meningitis Outsourcing Pharmacies Registration

Manufacturers Face Potential Roadblock to Early Challenges to Biologic Drug Patents

Biologic drugs have become increasingly popular in recent years, and now serve as standard treatment options for diseases such as diabetes, anemia, cancer, hepatitis, and multiple sclerosis. Biologics are a class of drugs or...more

11/22/2013 - Biologics Drug Manufacturers FDA Patents Pharmaceutical

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

11/18/2013 - ANDA Failure To Warn FDA Generic Drugs Labeling Mensing Pharmaceutical Wyeth

The FDA’s Latest One-Two Punch to Combat Drug Shortages

On October 31, 2013, the U.S. Food and Drug Administration (“FDA”) unveiled its latest steps for preventing and resolving prescription drug shortages. First, the agency announced a proposed rule requiring manufacturers of...more

11/7/2013 - Drug Manufacturers FDA FDASIA FDCA Pharmaceutical Prescription Drugs

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

12/17/2012 - FDA FDCA First Amendment Marketing Misbranding Off-Label Promotion Off-Label Use Pharmaceutical

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