Regulatory/Legislative News

The Drug Enforcement Administration has issued a DEA Manufacturer Controlled Substance Registration Certificate for Imprimis Pharmaceuticals’ FDA-registered outsourcing facility, the company announced in a press release.

President Donald J. Trump signed legislation on Jan. 22 that would sustain the Children’s Health Insurance Program for the next 6 years.

Prevent Blindness announced that it is urging Congress to enact long-term legislation for the Children’s Health Insurance Program.

In my last blog, “Backdoor health care reform,” some of my readers thought I might have revealed a political bias. I like to keep politics and health care separate, but there are occasions where the two subjects end up on a collision course.

The FDA issued a warning to Imprimis Pharmaceuticals regarding false or misleading information in promotional materials for its Dropless, LessDrops, Simple Drops and Klarity C-Drops products. The website and Twitter account for Imprimis include information claiming Simple Drops and Klarity C-Drops are made with FDA-approved components or are FDA approved, which is incorrect, while omitting risk information about the Dropless, LessDrops and Simple Drops products, according to a warning letter dated Dec. 21, 2017, and addressed to Imprimis CEO Mark Baum.

WAILEA, Hawaii ― At Hawaiian Eye 2018, Mark Baum, CEO of Imprimis Pharmaceuticals, discusses regulatory challenges facing compounding pharmacies and ways his company and others would like to work with physicians to bring changes to those hurdles.

New Jersey Governor Chris Christie signed into law on Jan. 8 a bill that prohibits health insurance companies from requiring that optometrists participate in vision care plans as a condition of inclusion on the carriers’ panel of providers.

The FDA has cleared the Omni Surgical System, according to a press release from Sight Sciences.

The FDA has granted tentative approval to Perrigo Company plc for its generic version of Prolensa, according to a company press release.

Shire plc and Shire Pharma Canada ULC announced the approval of Xiidra (lifitegrast ophthalmic solution 5%) for the treatment of dry eye disease in adults by Health Canada.