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Keeping you afloat amidst the rising sea of regulations

FDA Requires Pharma Companies to Certify Drug Listing Info

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations. The rule made some fairly substantial changes even though the rule became effective last November, and drug companies may just now start to feel the impact of some of the rule’s requirements.

Uncertainty Becomes the Norm…for 340B Rulemaking, at Least

On August 21, 2017, the Health Resources and Services Administration (HRSA) published a proposed rule (the Proposed Rule) that would entertain even further delays of the implementation of a January 5, 2017 Final Rule (the Final Rule) regarding calculation of 340B ceiling prices and the imposition of civil monetary

FDA Issues Draft Guidance For Product Identifier Requirements

Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act--Compliance Policy, with a 60-day comment period ending around September 3, 2017.

Will Opioid Manufacturers Become the Next Big Tobacco?

With the federal response to the opioid crisis still under development, state and local governments continue to file lawsuits against the pharmaceutical companies that manufacturer these products, accusing them of misleading doctors and consumers about the risks of addiction.

FDA Publishes Action Plan Designed to Address Generic Drug Competition Barriers

On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency's rules have been, in the agency's view, “gamed” to create obstacles that delay generic drug approvals to reduce generic competition.

How FDA’s Program Alignment Initiative Will Impact Industries: An Insider’s Perspective

In his first major announcement since taking office, FDA Commissioner Scott Gottlieb, M.D. finalized a major reorganization plan that had been under development since 2013. The reorganization, termed “Program Alignment,” reassigns field staff based on product type rather than geographic regions. Under the new organizational model, inspection and compliance staff in FDA’s Office of Regulatory Affairs will specialize in the five commodities and two enforcement areas:

HRSA Delays Effective Date of 340B Final Rule…Again

In a notice published in the Federal Register on Friday, May 19, 2017, the Health Resources and Services Administration announced that it would further delay the effective date of a final rule applicable to all drug manufacturers participating in the 340B Drug Pricing Program.

Chemical & Life Sciences Litigation: Year In Review

As in previous years, 2016 brought us a combination of both expected and unexpected holdings by the Supreme Court and the Federal Circuit.

Implementation and Enforcement of 340B Final Rule Delayed

In a Federal Register notice scheduled to be published on March 20, 2017, the Health Resources and Services Administration (HRSA) announced that it will delay the effective date of the January 5, 2017 final rule (the Final Rule) that provided guidance on the calculation of drug ceiling prices and the imposition of civil monetary penalties on certain drug manufacturers participating in the 340B Drug