All posts by Cooley

CMS Call for Comments Re: Sunshine Act

The Centers for Medicare & Medicaid Services (CMS) recently issued a Federal Register notice requesting comments related to the Sunshine Act, section 6002 of the Affordable Care Act.  Specifically, CMS is requesting comments on the implementation of the registration process, attestation process, dispute and resolution processes, assumptions document, and data retention requirements […]

No Doubt About It: Sunshine Reporting Will Draw Interest

Since the introduction of the Sunshine Act legislation several years ago, one question has been whether transparency will impact relationships between pharmaceutical and medical device manufacturers and health care providers and entities.  Others have wondered whether patients, enforcement authorities and the public at large will be interested in the reported data.  While these […]

TIME IS UP! Sunshine Data Tracking Starts Today

The day long awaited by the health care industry has finally arrived.  Today is the day that pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) must begin tracking payments and other transfers of value provided to “covered recipients” in accordance with Section 6002 of the Affordable Care Act (commonly […]

Wyeth’s $491 Million Fraud Settlement

The U.S. Department of Justice (DOJ) announced on July 30, 2013 that it had reached a settlement with Wyeth Pharmaceuticals to resolve criminal and civil liability related to the unlawful marketing of its prescription drug Rapamune for uses not approved by the U.S. Food and Drug Administration (FDA) that caused false claims to be submitted […]

Additional Transparency for Clinical Trials Announced by Industry Groups

On July 24, 2013, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) announced joint endorsement of the “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.”  These principles applicable to biopharmaceutical companies take effect January 1, […]

LITIGATION ROUND-UP

Settlements The U.S. Department of Justice (DOJ) announced on July 18, 2013 that pharmaceutical manufacturer Mallinckrodt LLC agreed to pay $3.5 million to settle a civil False Claims Act suit. The complaint alleged that Mallinckrodt paid illegal kickbacks to health care professionals in the form of speaker honoraria, clinical trials funding, and honoraria […]

FDA Continues Enforcement Against Internet Marketing of Unapproved and Misbranded Drugs

EvaPharmacy recently received a Warning Letter from the United States Food and Drug Administration (“FDA”), Office of Drug Security, Integrity and Recalls regarding products available for sale to consumers in the United States on its websites.  The FDA requested that EvaPharmacy take prompt action and notify the FDA within ten […]

Electronic Submissions Now Available for OIG Voluntary Disclosures

The Office of Inspector General of the Department of Health and Human Services (“OIG”) released an on-line Provider Self-Disclosure Protocol (“Protocol”) submission form for individuals and entities that seek to disclose to the OIG potential violations of criminal, civil, or administrative law governing health care programs for which exclusion or […]

FDA Issues Draft Guidance on Reporting Adverse Events for Medical Device Manufacturers

The Food and Drug Administration Center for Devices and Radiological Health released draft guidance on July 9, 2013 titled, Medical Device Reporting for Manufacturers.  Written comments may be submitted by mail or electronically to the FDA within 90 days.  When finalized, the guidance will supercede the 1997 guidance document with the […]

No Relief in Minnesota from Reporting Obligations

On June 24, 2013, the Minnesota Board of Pharmacy posted a letter to pharmaceutical manufacturers and drug wholesalers informing them that the Board’s request to the Minnesota legislature to repeal Minnesota Stat. §151.47(1)(f) did not occur. Rather, the Minnesota legislature modified the statute related to reporting obligations. The Minnesota Board […]