This bill — the Strengthening Health Care and Lowering Prescription Drug Costs Act — would combine seven bills which aim to strengthen protections for pre-existing conditions and lower prescription drug costs. Among its provisions include provisions to ban “junk” health insurance plans, expand marketing & outreach under the Affordable Care Act (aka Obamacare) while providing funding for states to set up exchanges, and get generic drugs and biosimilars to market sooner. A breakdown of its various provisions can be found below.
Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act
This bill would aim to promote a more competitive drug market by creating a pathway for expediting the launch of generic drugs. It’d crack down on anti-competitive practices by branded drug manufacturers by allowing the purchase of samples, which are needed for generic companies to develop and test generic products side-by-side with branded products.
It’d also ensure that generic companies are able to access branded companies’ Risk Evaluation Mitigation Strategy with Elements to Safer Safe Use (REMS with ETASU) protocols, which are necessary safety protocols for certain types of drugs.
When access to samples is blocked, this bill would permit a biosimilar or generic manufacturer to sue in federal court for injunctive relief to obtain the sample it needs for development. In such cases, limited damages could also be awarded as a deterrent in certain egregious cases.
This bill also gives the FDA more discretion to approve alternative safety protocols, rather than requiring the branded and generic companies to develop shared safety protocols. However, any safety protocol would still have to be approved by the FDA and must meet the same rigorous safety standards as those already in place.
Protecting Consumer Access to Generics Act
This section would prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market. It would also prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of their products to the market.
Bring Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act
This section would aim to promote competition among generic manufacturers and deter a first generic applicant from “parking” their application and delaying its final approval, which in turn delays subsequent applications by other generic manufacturers (first applicants have 180 days of exclusivity for their generic after going to market). It would allow the Food and Drug Administration (FDA) to approve a subsequent generic application if the following conditions are met:
The subsequent application is ready for full approval;
At least 30 months have passed since the first applicant submitted their application;
Related patent litigation has been fully resolved by at least one first applicant; and
No first applicant has received final approval.
“Junk plan” ban
This section would block Trump administration executive actions regarding health insurance regulations by reversing the expansion of short-term, limited-duration health plans for consumers.
State Allowance for a Variety of Exchanges (SAVE) Act
This section would establish a $200 million per year grant program to assist states in establishing health insurance exchanges.
Expand Navigators’ Resources for Outreach, Learning and Longevity (ENROLL) Act
This section would amend the Patient Protection and Affordable Care Act (aka Obamacare) to guarantee $100 million in annual funding for Navigator initiatives that help people pick the best health plans for themselves and their families. It’d also boost outreach and educational activities to raise the accessibility of information about coverage options and financial assistance to help purchase coverage. Funding for this bill would come out of the user fees imposed on participating health insurance issuers in insurance marketplaces.
MORE Health Education Act
This section would provide $100 million in annual funding for marketing and outreach activities to promote the federal health insurance marketplace.