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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Month: February 2018
- Going Strong! Orphan Drug Approvals and Designations Skyrocketed in 2017, While Orphan Drug Designation Requests Dipped SlightlyFebruary 28th, 2018
- The PEW Charitable Trusts Releases Report on the State of Human Drug Compounding by Traditional Pharmacies and Outsourcing FacilitiesFebruary 27th, 2018
Today the PEW Charitable Trusts released a detailed report on the general state of pharmacy compounding of human drug products in the United States. The Report focuses on compounding pharmacies, but addresses both sterile and non-sterile compounding regulation by states. The Report also touches on …
- 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 …
- FDA Publishes Final Rule and Guidance on Acceptance of Clinical Data to Support Medical Device Applications and SubmissionsFebruary 23rd, 2018
On February 21, FDA published a final rule amending its regulations on the acceptance of data from clinical investigations for medical devices (83 Fed. Reg. 7366). These amendments are designed to ensure the quality and integrity of clinical data and the protection of human subjects. …
- FDA Issues Draft Guidance for Preparing a Pre-Request for DesignationFebruary 22nd, 2018
On February 15, FDA’s Office of Combination Products (OCP) announced the draft guidance, “How to Prepare a Pre-Request for Designation (Pre-RFD).” Don’t let the name fool you though. Unlike the similarly named Pre-Submission, a Pre-RFD does not need to precede a formal RFD. A Pre-RFD …
- About Time: DEA Acknowledges that Long-Collected ARCOS Data is an Effective Enforcement Tool That Can Assist Manufacturers and DistributorsFebruary 21st, 2018
Overprescribing and inappropriate prescribing of controlled substances are significant causes of the nationwide opioid abuse epidemic. We have long believed that to effectively address the opioid epidemic, the Drug Enforcement Administration (“DEA”) must focus on physicians and other practitioners who fail to comply with legitimate …
- 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 …
- FSIS Proposes Egg Products HACCP Rule That Expands JurisdictionFebruary 19th, 2018
On February 13, 2018, the USDA Food Safety and Inspection Service (FSIS) published a proposed rule that would amend the egg products inspection regulations. The proposal had been announced on January 9, 2018. The 48-page proposal (including the preamble) covers more than a change in …
- 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 …
- Traditional vs Clean Meat: Cattlemen Ring the Bell for Round 1February 15th, 2018
Clean or cultured meat are terms used for animal muscle produced by growing cells directly rather than via the rearing and slaughtering of an animal. The idea of growing meat (or muscle) from cells outside the body (in vitro) to produce a product that replicates …
- A Heavy Homework Assignment for Food Importers and ProducersFebruary 14th, 2018
Barely a week apart, FDA announced the publication of a slew of guidance documents intended to further implement the food supply chain-related provisions of the Food Safety Modernization Act (FSMA). In this posting, we look at the first set of documents, published on January 24. …
- 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 …
- Are You Talking? Because CDRH Says It’s Listening (At Least If You Are In the Digital Health Space): Notes from A Two Day WorkshopFebruary 11th, 2018
The Center for Devices and Radiological Health (CDRH) says it has a plan for fostering digital health innovation while reimagining the regulatory oversight to provide patients with access to safe and effective digital health products. One step in the plan is developing a Digital Health …
- FDLI’s New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century CuresFebruary 8th, 2018
On Friday, February 9, 2018, from 2:00-3:30 PM ET, the Food and Drug Law Institute (“FDLI”) will be hosting a webinar, titled “New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures.” Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs …
- CDRH Publishes Metrics for Third-Party 510(k) ReviewsFebruary 7th, 2018
The third-party 510(k) review process was an emphasis in the most recent user fee negotiations and statutory changes under the FDA Reauthorization Act of 2017 (FDARA). This process has been criticized in the past for being restrictive, ineffective, and not beneficial for applicants. On January …