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Will Any of FDA’s Recent Rules Wind Up On the Congressional Chopping Block?
…Licensed Prior to July 1, 1972; Technical Amendment New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application New Animal Drugs: Approval of New Animal Drug Applications; Withdrawal…
Did You Catch That “New” Drug Product Addition to the Orange Book?
…[e.g.,Donnatal® Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication.” And it was just a few months ago that FDA identified LIBRAX as…
Every Breath You Take . . . FDA is Watching You!
…and maintained but does that include for example court records from divorce proceedings or child custody cases? What about financial contributions to political candidates? The government’s description says only that…
The FTC Takes Action for Alleged Anticompetitive Citizen Petitioning Activities Surrounding Generic VANCOCIN
…lucrative franchise, ViroPharma inundated the FDA with regulatory and court filings—forty-six in all—to delay the FDA’s approval of generic Vancocin Capsules. That number is, by far, the most filings that…
340B Rule Sinks Deeper Into Regulatory Freeze
…(“HRSA”) of HHS issued a final regulation describing the methodology for calculating the 340B ceiling price (including so-called penny pricing) and to establish civil monetary penalties for knowing and intentional…
Implementation of 340B Final Rule Postponed Until October 1, 2017
…2017 the implementation of a final regulation establishing the methodology for calculating the 340B ceiling price (including so-called penny pricing) and civil monetary penalties (CMPs) for knowing and intentional overcharges…
First Generic Drug Price Gouging Prohibition to Become Law in Maryland
…is a prescription drug (1) with no unexpired marketing exclusivity under the Federal Food, Drug, and Cosmetic Act; (2) that either appears on the World Health Organization’s model list of…
Supreme Court Ruling on SEC Statute of Limitations May Affect Other Agencies’ Pursuit of Disgorgement
…qualify as a criminal penalty that should bar later criminal proceedings. Finally, Kokesh has the ancillary consequence of calling into (further) question whether disgorgement payments are tax deductible, an issue…
Ninth Circuit Revives False Claims Act Case Applying Escobar Materiality Standard
…Escobar. On July 7, 2017, the Ninth Circuit bucked the trend, reversing the lower court’s dismissal of an FCA case against Gilead Sciences, Inc. In United States ex rel. Campie…
HHS Proposes Longer Delays to Implementation of the 340B Final Rule
…Proposed Rulemaking (“NPRM”) that would delay until July 1, 2018 the implementation of the Final Rule establishing the methodology for calculating the 340B ceiling price (including the so-called penny pricing…
HHS Will Delay 340B Final Rule Implementation to July 2018
…Final Rule], as well as allowing a more deliberate process of considering alternative and supplementary regulatory provisions, and to allow sufficient time for additional rulemaking.” 82 Fed. Reg. 45512. Similar…
Senator Lamar Alexander Asks HHS to Clarify Its Policy on Allowing Patients Direct Access to Health Information
…information available directly to consumers, as shown by the final rule allowing clinical laboratories to give complete test reports directly to patients, published by the Office of Civil Rights, Center…
The CREATES Act Would Create a Cause of Action to Obtain Restricted Product Sample and to Facilitate Shared REMS
…to seek approval of a generic drug or biosimilar biological product. Provided certain elements are met, a court may “order the license holder to provide to the eligible product developer…
Another Mystery Solved: DEA Issues a Final Decision Revoking Morris & Dickson’s Registration: Or Has It?
CBS News caused a bit of commotion last week in reporting that after a four-year delay, DEA issued a final order revoking Morris & Dickson’s DEA registration. However, until today…
Attorney General Lynch Delivers a Public Service Announcement About DOJ’s Enforcement Actions for Unsafe Dietary Supplements
…Attorney General Lynch’s message reinforces the November 2015 announcement that after a year-long effort, DOJ had engaged in over 100 criminal and civil cases against dietary supplement manufacturers and marketers….