By Kurt R. Karst – The first iteration of the Generic Drug User Fee Amendments (“GDUFA”) – “GDUFA I” – is now well into Year 4 of the 5-year program, and anticipation is growing as to what the second iteration of the program – “GDUFA II” …
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Prescription Drugs and Biologics
- RLD Designation Citizen Petitions: One Item on Our GDUFA II Wish ListMay 18th, 2016
- Congress’ Dubious Delegation of Legislative Authority to USP Standards Results in “Instructions”– But Not “Dismissal” – Related to the NECC Criminal IndictmentMay 12th, 2016
By Karla L. Palmer – A Massachusetts United States district court judge decided last week whether the United States’ reliance on alleged violations of the United States Pharmacopeia (“USP”) compendium addressing sterility of compounded preparations was a permissible delegation of legislative power to USP to define …
- HP&M Seeks Alternative Statutory Reading of BPCI Act “Deemed to be a License” ProvisionMay 9th, 2016
By James E. Valentine & Josephine M. Torrente – In March, FDA published a draft guidance document that describes FDA’s approach to the implementation of the statutory provision in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) under which an …
- FDA Revises Guidance on Special Protocol Assessments, Attempts to Reduce UncertaintyMay 9th, 2016
By James E. Valentine & Alexander J. Varond – FDA recently issued draft guidance, entitled “Special Protocol Assessment,” which, when finalized, will replace FDA’s 2002 final guidance by the same title. At 23-pages long, the draft guidance is much more thorough than its predecessor (only 11 …
- Speculating About the Prospects of Exclusivity – A Potentially Risky GameMay 5th, 2016
By Kurt R. Karst – Speculating about the prospects that FDA will grant a period of marketing exclusivity – 5-year New Chemical Entity (“NCE”) exclusivity, 3-year new clinical investigation exclusivity, 7-year orphan drug exclusivity, or any other type of exclusivity or add-on exclusivity – upon the …
- The COMBAT Act Would Add New Brand and Generic Exclusivity-Stacking Incentives for Abuse-Deterrent Opioid DevelopmentMay 2nd, 2016
By Kurt R. Karst – On April 29, 2016, Represetatives Gerry Connolly (D-VA) and Morgan Griffith (R-VA) announced the introduction of H.R. 5127, the “Curb Opioid Misuse by Advancing Technology (COMBAT) Act.” The COMBAT Act is the latest effort by Congress to incentivize the development of …
- Tested Mettle: Vifor Fresenius Petitions FDA to Make a Decision on NCE Exclusivity for Iron-based Phosphate Binder VELPHOROApril 27th, 2016
By Kurt R. Karst – Disputes involving non-patent marketing exclusivity available to 505(b)(1) and 505(b)(2) NDA applicants – either 5-year New Chemical Entity (“NCE”) exclusivity, 3-year new clinical investigation exclusivity, or 7-year orphan drug exclusivity – have increased dramatically over the past few years, and there’s …
- Does FDA’s Per Se Prohibition Against Off-Label Promotion Have a Future?April 26th, 2016
The short answer to that question is “No,” says Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro in an article published in the March/April 2016 issue of the Food and Drug Law Institute’s Update Magazine. Mr. Shapiro examines the Department of Justice’s recent criminal prosecution of …
- What the Doctor Ordered? What the Pharmacist Understood? FDA Issues Compounding Draft Guidance Addressing Compounding for Office Use under FDC Act § 503AApril 21st, 2016
By Karla L. Palmer – On April 15, 2016, FDA released a draft guidance document providing clarification concerning FDA’s position on prescription requirements for compounding human drug products for identified individual patients. Since the 2013 passage of the Drug Quality and Security Act, there has been …
- FDA Addresses “Facility Definition” For Outsourcing Facilities: Manufacturers Can Live With Outsourcing Facilities But Section 503A Compounders CannotApril 21st, 2016
By Karla L. Palmer – On April 18, 2016, FDA released draft guidance addressing what it considers a “facility” under FDCA Section 503B (the section of the Drug Quality and Security Act that created outsourcing facilities back in 2013). The draft guidance was prompted FDA was …
- The FTC’s “Pay-for-Delay” Lawsuit Against Endo: Is There a Hole in the Commission’s Generic LIDODERM 180-Day Exclusivity Analysis?April 19th, 2016
By Kurt R. Karst – Last month, the Federal Trade Commission (“FTC”) announced the filing of a Complaint For Injunctive and Other Equitable Relief in the U.S. District Court for the Eastern District of Pennsylvania alleging that Endo Pharmaceuticals Inc. (“Endo”) and other drug manufacturers, including …
- Proposed Legislation Would Create a New Conditional Approval Pathway to Market for Regenerative Medicine ProductsMarch 31st, 2016
By Jeffrey K. Shapiro & Charlene Cho – In the emerging world of regenerative medicine, there is a stark dichotomy in the level of regulation applied to products derived from human cells and tissues, or what FDA calls “human cells, tissue or cellular and tissue‑based products” (HCT/Ps). If …
- Compounding the Dilemma over the Permissibility of Office Use Compounding: Congressman Requests Answers to Questions from HHS Secretary BurwellMarch 29th, 2016
By Karla L. Palmer – On Tuesday, March 15, 2016, HHS Secretary Burwell testified before the House Education and the Workforce Committee, during which Representative Buddy Carter (R. Ga.), who is a pharmacist, asked Secretary Burwell about office use compounding. Representative Carter expressed his concern about …
- Amgen Asks the Supreme Court to Reject Challenge to Ruling that Notice of Commercial Marketing is Mandatory, But Asks for Review of Patent Dance Ruling Just in CaseMarch 29th, 2016
By James C. Shehan – On March 21, 2016, Amgen filed a brief opposing Sandoz’s request that the Supreme Court overturn last year’s Federal Circuit ruling that the Biologics Price Competition and Innovation Act’s ("BPCIA's") notice of commercial marketing provision is mandatory and can only be …
- Orphan Drug Clinical Superiority: An Overview of Precedents Shows that MC-to-PC Clinical Superiority is Not so UnusualMarch 27th, 2016
By Kurt R. Karst – For several years now we have been following instances in which FDA designated, and later approved, a drug (including a biological product) as an “orphan drug” on the basis that it is not the “same drug” as a previously approved product …