February 28, 2018 is Rare Disease Day. In honor of that day, we thought it would be the perfect time to provide our annual rundown of the past calendar year in orphan drug designations and approvals. And what a year 2017 was for orphan drugs! …
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Prescription Drugs and Biologics
- Going Strong! Orphan Drug Approvals and Designations Skyrocketed in 2017, While Orphan Drug Designation Requests Dipped SlightlyFebruary 28th, 2018
- FDA Implements FDARA Provision on Orphan Drug Clinical Superiority DeterminationsFebruary 26th, 2018
Obtaining FDA decisions detailing when one orphan drug has been determined by the Agency to be “clinically superior” to another orphan drug – either to obtain approval of a product notwithstanding another company’s orphan drug exclusivity for the same drug for the same indication, and/or …
- DC District Court Denies Ferring Motion to Enforce Judgment After FDA’s Surprise Change on NCE Exclusivity for PREPOPIKFebruary 20th, 2018
The years-long battle over 5-year New Chemical Entity (“NCE”) exclusivity for Ferring Pharmaceuticals Inc.’s (“Ferring’s”) colonoscopy preparation, PREPOPIK (sodium picosulfate, magnesium oxide, and citric acid) for Oral Solution (NDA 202535; approved on July 16, 2012), may finally be at an end (pardon the pun). Last …
- Trump Budget Proposal Would Further Cheapen Generic Drug 180-Day ExclusivityFebruary 16th, 2018
On Monday, the Trump Administration released a proposed Fiscal Year 2019 Budget. Tucked into the Proposed Budget are provisions concerning 180-day generic drug exclusivity that garnered quite a bit of discussion earlier this week at the Annual Meeting of the Association for Accessible Medicines in …
- Budget Act Increases Brand Drug Companies’ Discounts Under Government ProgramsFebruary 12th, 2018
Buried in the 250 pages of the Bipartisan Budget Act of 2018 (BBA 2018), which was signed by President Trump on Friday, February 9, are several provisions directly affecting the discounts brand drug manufacturers must pay under federal drug benefit programs: Increase in Part D Coverage …
- Join Us in April to Learn More about Improving Regulatory Compliance While Minimizing Products Liability!February 5th, 2018
The fact is, regulatory compliance has an impact on products liability. Yet, the two are seldom considered together. We aim to change that with a special day and a half program (April 12th and 13th). Our FDA regulatory firm has teamed up with a renowned medical …
- In a Flurry of Activity, FDA Releases Compounding Final Guidances Addressing “Essentially Copies” of Commercially Available Drug Products for Both Section 503A and 503B CompoundersJanuary 24th, 2018
As stated in our blogpost discussing FDA’s announcement of 2018 Compounding Policy Priorities (here). FDA also released its Final Guidance on Compounding “essentially copies” of commercially available drugs. This long-anticipated guidance discusses how FDA intends to determine whether a compounded drug is essentially a copy …
- FDA Proposes To Delay Revision to Intended Use RegulationJanuary 23rd, 2018
In 2015, FDA proposed to revise the intended use regulations, which describe how the agency determines the intended use of a drug or device, including the types of evidence that may be considered. FDA’s proposed rule would have deleted the infamous “knowledge” sentence, which could …
- Compounding Remains an FDA Priority: Agency Announces 2018 “Compounding Priorities Plan” and Several Compounding Guidances, Including Guidance on “Essentially Copies” and RepackagingJanuary 22nd, 2018
Last week FDA announced the release of its 2018 “Compounding Priorities Plan.” FDA also released several guidance documents in the wake of its announcement, such as its final guidance on essentially copies of commercially available drug products for Section 503A and 503B facilities (more on …
- New Jersey Finalizes New Limits on Pharmaceutical Manufacturer Gifts and Payments to PrescribersJanuary 17th, 2018
As we previously reported, in October 2017, the New Jersey Attorney General and Division of Consumer Affairs issued a proposed rule in response to concerns about the amount of money being paid to prescribers in the state of New Jersey. On December 22, 2017, the …
- Court May Confirm the Rigorous Materiality Standard Required by the False Claims ActJanuary 9th, 2018
To prevail on an allegation under the False Claims Act (FCA), a plaintiff must allege that the misrepresentation by defendant was “material to the Government’s payment decision.” Universal Health Services, Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016). The U.S. Supreme …
- Litigation Briefing: HP&M Issues Report Summarizing Leading Cases and Settlements of 2017January 8th, 2018
Hyman, Phelps & McNamara, P.C. is pleased to present this report summarizing leading cases and settlements from 2017 affecting the FDA-regulated industry. Our goal was to provide a concise summary of issues that most impact our clients, many of whom are drug and medical device …
- Continued Interest in Drug Categorization – OIG Finds Ten Potentially Misclassified Drugs May Have Led to $1.3 Billion in Lost Medicaid RebatesJanuary 4th, 2018
On December 20, 2017, the Department of Health and Human Services, Office of Inspector General (OIG) published a report entitled “Potential Misclassifications Reported by Drug Manufacturers May Have Led to $1 Billion in Lost Medicaid Rebates.” This report is the result of Congress’ September 2016 …
- Jury Was Entitled to Hear Advice-of-(Second)-Counsel Defense: Conviction ReversedDecember 28th, 2017
The U.S. Court of Appeals for the Second Circuit issued a decision a couple of weeks ago reversing the conspiracy conviction of a defendant for distribution of unapproved drugs, among other things. The trial court had rejected evidence relating to an advice-of-counsel defense asserted by the …
- FDA Updates Guidance for Homeopathic Drugs; Increased Scrutiny for Certain Categories of ProductsDecember 22nd, 2017
On December 18, 2017, FDA announced the availability of a new draft guidance for homeopathic drugs. This guidance, when finalized, will replace the compliance policy guide (CPG) 400.400 from 1988. Homeopathy is based on an 18th-century idea that substances that cause disease symptoms can, in very small …