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D.C. Circuit Reverses Lower Court, Clearing the Way for CMS Cuts in Drug Payment to 340B Hospitals
…6% to ASP minus 22.5%) would bring payment rates in line with actual drug acquisition costs under the 340B program. The court rejected the hospitals’ argument that, under Clause (II),…
Operation Warp Speed and the Standard for Review of the COVID-19 Vaccines
…would need to be widely disseminated in clinical trials, including with sufficient representation of racial and ethnic minorities, older adults, and individuals with medical comorbidities. Finally, the article states that…
CDRH Issues Draft Guidance Regarding Patient Reported Outcomes
…PROs in regulatory decision making, including through publication of PRO case studies and a PRO Compendium outlining instances in which PROs were used in clinical studies in fiscal years 2014…
Discount “Stacking” in Medicaid Rebate Best Price Addressed by Federal District Court
On November 5, the Maryland Federal District Court dismissed a Federal False Claims Act qui tam suit alleging that Forest Laboratories knowingly reported inflated best prices under the Medicaid Drug…
OIG Fires Another Warning Shot at Drug and Device Companies’ In-Person Speaker Programs
…account the volume or value of past business generated or potential future business generated by the HCPs. The OIG acknowledges in the Fraud Alert that many in-person activities have been…
Festivus for the Rest of Us: How Competitors Can Air Grievances with the New Administration
A new administration always brings with it the excitement of new political appointees, briefing books and never-ending speculation about forthcoming changes in the direction of various agencies. It also brings…
OIG Finalizes Safe Harbor Amendments Relating to Rebates, but Benefits to Patients Are Unclear
…if the revised regulatory impact statement adds anything to the earlier analyses. For one, the CBO estimates appears to have already considered some of the behavior changes that the final…
FDA Finalizes Guidance on Obtaining Agency Feedback on Combination Products; Highlights Best Practices for Meeting and Communicating with FDA
…contacted with preliminary or general questions, or to discuss whether an application-based mechanism or CPAM is more appropriate. Meetings with FDA: Traditional vs. CPAM Traditional application-based mechanisms include the pre-submission…
Responding To Recalls May Be a Walk in the Park for FDA
By Oisin A. Mulvihill* & Peter M. Jaensch – A recent string of high-profile pharmaceutical and medical device product recalls appears to be reigniting FDA’s interest in pressing misdemeanor charges…
Act II, Scene II: A Rose By Any Other Name Would Smell as Sweet? “No!” Says GPhA in Citizen Petition to FDA on Biosimilar Naming
…like the Alliance for Safe Biologic Medicines (“ASBM”). As we previously reported, ASBM has urged FDA to adopt unique non-proprietary names for all biological products licensed under the PHS Act,…
Of Fish, Milk, and Beets: Biotech Heats Up (Again)
…of milk derived from cows not treated with rbST continues more than 15 years after that drug’s approval (rbST stands for “recombinant bovine somatotropin,” a bioengineered hormone that increases milk…
In Appeal Over Colchicine 505(b)(2) Approval, Plaintiffs-Appellants and PhRMA Allege Lower Court Decision Upsets Hatch-Waxman Scheme
…critical safety information it had previously deemed essential. After Mutual’s groundbreaking studies, FDA determined that information about dose adjustments and a low-dose colchicine regimen was mandatory for all single-ingredient oral…
FDA’s Biosimilar Labeling Guidance
…and the pregnancy and lactation labeling rule, regardless of whether the labeling of the reference product does or does not follow those rules. Turning to specific issues, FDA states that…
Orphan Drug Clinical Superiority: An Overview of Precedents Shows that MC-to-PC Clinical Superiority is Not so Unusual
…with history of highly symptomatic atrial fibrillation/flutter. To the extent FDA Law Blog readers are aware of additional clinical superiority approval precedents, we’re all ears. Greater Effectiveness Clinical Superiority Determinations…
Congress Puts Pressure on FDA and Proposes Incentives to Ramp Up Generic Drug Reviews
…clinical studies to be eligible for a voucher, and requiring the Comptroller General to conduct a review of the implementation and effectiveness of Risk Evaluation and Mitigation Strategies (“REMS”) (including…