Regulatory/Legislative News

In 2018, after President Donald Trump publicly condemned the pharmaceutical industry for skyrocketing prescription drug prices, several of the largest drug manufacturers — including Merck, Novartis, Pfizer and Roche — announced a series of temporary price freezes to their brand-name medications.

The FDA has accepted an investigational new drug application for AR-1105, a treatment candidate for macular edema due to retinal vein occlusion, Aerie Pharmaceuticals announced in a press release.

The cover story in the Dec. 25, 2018, issue of Ocular Surgery News focused on the FDA approval process for ophthalmology in 2018.

Leaders from several states vowed appeals to stave off the consequences to health care after a district judge from Texas ruled that when Congress eliminated the penalty for not buying health insurance, the individual mandate was no longer constitutional under Congress' taxation powers, The Los Angeles Times reported.

If you want to know the future, look no further than the FDA’s coming Prescription Drug User Fee Act announcements calendar. While not all drugs reviewed by the FDA will obtain future approval, these are the dates that the FDA typically announces its decision whether or not to approve a new drug application. In ophthalmology, 2019 looks to be promising in glaucoma, macular degeneration and the treatment of anterior segment inflammation.

The American Academy of Ophthalmology agrees with a joint federal report’s recommendations on scope of practice, the organization announced in a press release.

The United States-Mexico-Canada Agreement keeps drug prices high but could potentially spur new research opportunities, a pharmaceutical expert told Healio Family Medicine.

The Trump administration’s latest effort to reduce drug prices met with generally positive reviews from policy analysts, who also noted the difficult path ahead to put the plan into effect.

CMS has issued a product-specific J code for Photrexa formulations used in corneal collagen cross-linking, Avedro announced in a press release.

The average premium for the second lowest cost silver health insurance plans — the one used to determine final premium tax credits — will drop by a “historical” 1.5% for the first-time since the implementation of the federally-facilitated Exchange in 2014, according to CMS.