The House of Representatives passed two bills aimed at speeding up the development of generics and biosimilars while the Trump administration finalized a rule to require drug companies to list the price of their products in their television ads.
The House passed two bills to address drug pricing. The House passed H.R. 1503, the Orange Book Transparency Act of 2019, legislation that would make changes to the FDA’s “orange” book to provide better information on brand drug and patent exclusivity. The orange book is used by doctors and pharmacists for information on generic drug approvals and availability. It is also used by generic drug manufacturers to make decisions on where to invest in research and development as it provides information on the exclusivity period for brand name drugs. Similarly, the House passed H.R. 1520, the Purple Book Continuity Act, legislation that would update FDA’s “purple” book on patents and exclusivity for biologics. These are the first bills of the 116th Congress to pass that address the costs of drugs.
The Administration finalizes rule on drug costs in advertising. The Trump administration finalized a rule that would require drug manufacturers to disclose prices on their products in television advertisements. Manufacturers must list a product’s monthly wholesale price or the cost of a typical treatment if it is greater than $35 for 30 days. The information must appear in text large enough for people to read it and should also include a statement that people with insurance may pay a different amount for the product. The rule takes effect in 60 days and the drug industry opposes the rule, which they say could sway patients away from certain medications and lead to more misinformation on the actual costs.
House Appropriations Committee approves $2 billion NIH increase. The House Appropriations Committee approved their fiscal year 2020 Labor, HHS, and Education Appropriations bill that includes a $2 billion increase in NIH funding. The Committee also includes critical report language on several GI research areas including inflammatory bowel disease, colorectal cancer screenings, early onset colorectal cancer, and the role of food as medicine in treating diseases. The bill also includes important language directing CMS to require Medicare Advantage plans to exclude from prior authorization requirements those services that align with evidence-based guidelines and have a high prior authorization approval rate. The language also calls for more transparency for MA plans with prior authorization so physicians are aware of what services require it.
Medical Nutrition Equity Act introduced in House. Rep. Jim McGovern, D-Mass., introduced H.R. 2501, the Medical Nutrition Equity Act, legislation that would mandate coverage of medically necessary foods for individuals with digestive and inherited metabolic disorders. AGA is supportive of this legislation that is critical for patients with digestive diseases and ensures their access to these lifesaving products.