Ophthalmologists can face pressures from myriad sources, including lawmakers in Washington, D.C. Keeping tabs on activities on Capitol Hill that could impact ophthalmologists is one of the jobs of Cathy Grealy Cohen, CAE, MHSA, vice president for government affairs at the American Academy of Ophthalmology.
Cohen noted both Congress and the Trump administration are targeting drug costs as a priority.
“You really do have a matched agenda here. You are going to see some legislation passing where there is consensus to stop the gaming that the brand companies are playing, their pay for delay,” she said.
CREATES Act on Hill
Another item is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which would enable generic manufacturers to get access to the samples so that they can make generic versions of drugs. In February, lawmakers reintroduced the CREATES Act.
Legislators on Capitol Hill contend the bill would combat tactics they claim brand-name drug companies use to allegedly impede generic and biosimilar competition.It is projected to save nearly 4 billion for the federal government by enabling generic and biosimilar developers to secure the required samples of a reference drug or biologic to demonstrate interchangeability, bioequivalence or biosimilarity.
The House has now advanced the CREATES Act, and three other pieces of bipartisan legislation designed to promote competition and lower drug prices. The Senate committees have included key provisions in legislation moving forward in that body and a floor vote on their drug cost legislation could take place as early as September. The bills are not expected to have a dramatic impact on prescription drug medications in the short term, but they reportedly could level the playing field for generic drug companies.
In addition to the CREATES ACT (HR 965), other measures under consideration include HR 2375, the Preserve Access to Affordable Generics and Biosimilars Act, which would halt anticompetitive agreements between generic and brand name manufacturers; HR 2374, the Stop STALLING Act, which would seek to stop the submissions of sham citizen petitions to the FDA; and HR 2376, the Prescription Pricing for People Act of 2019, which was advanced by a voice vote and would enlist the Federal Trade Commission to study and report on pharmacy benefit managers and whether they steer patients to certain pharmacies for anticompetitive purposes.
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Cathy Grealy Cohen, CAE, MHSA
P: 415/561.8500 E: [email protected]
This article was adapted from Ms. Cohen’s presentation at the American Glaucoma Society annual meeting. She has no financial interests to disclose.