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Creating a Marketplace that Works for Patients

The challenge of high and rising drug prices affects almost all Americans – and voters are unified in demanding Congress to take action. Drug companies have pushed the price of life-saving medications higher and higher and have abused anticompetitive loopholes to game the regulatory system. These unfair advantages give drug companies immense power and severely restrict the ability of the free market to bring prices down.

The good news? Congress is taking action. The House of Representatives is expected to consider H.R. 987, the Strengthening Health Care and Lowering Prescription Drug Costs Act, which packages together provisions which will help curb pharma’s anticompetitive tactics. These measures will increase the speed at which generic competition comes to market, and put patients first by fostering an environment that works to ensure they have access to medicines they need at a price they can afford.

To help build a stronger, more competitive marketplace for prescription drugs that works for patients, CAPD specifically supports the following provisions:

1. Preventing REMS and equivalency-testing abuse. (Previously H.R. 965, “Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019”)

  • What this does: This proposal seeks to enable manufacturers looking to develop generics or lower-cost alternative medicines by providing access to product samples necessary for FDA-required equivalency testing. If they are denied samples, they would be permitted to bring action against a brand or biologic manufacturer who is attempting to block their development.
  • How this will help: Stopping the anti-competitive blocking tactics used by some brand manufacturers will help consumers benefit from new, lower-cost generic drugs faster.

2. Barring anticompetitive “pay-for-delay” agreements. (Previously H.R. 1499, “Protecting Consumer Access to Generic Drugs Act of 2019”)

  • What this does: This proposal would make it illegal for brand and generic drug manufacturers to enter into “pay-for-delay” agreements in which the generic manufacturer agrees to delay entry into the marketplace.
  • How this will help: Brand drug companies use “pay-for-delay” agreements to further inflate drug prices and extend the life of their patents. Ending these anti-competitive agreements will boost competition and, in turn, incentivize the introduction of lower-cost alternatives into the market.

3. Allowing second and third generic drugs to come to market faster. (Previously H.R. 938, “Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019”)

  • What this does: First-to-file generic manufacturers are awarded 180-day exclusivity from the FDA, but this can block other competing generic manufacturers from coming to market. This bill would start the first manufacturers’ 180-day exclusivity period immediately if a second generic drug application is blocked from FDA approval solely due to the first generic drug manufacturer delaying their exclusivity period from taking effect.
  • How this will help: Generics can help bring prices down, but they are most effective when there are more options competing in the market. By ending the ability of generic manufacturers that come first to the market to block other competitors indefinitely, patients can benefit from robust competition that drives prices down quickly and efficiently.

These measures are a good first step, and Congress should support them and continue its efforts to make the market for prescription drugs more competitive and help lower prices for patients. Learn more about common-sense policy fixes that CAPD supports here.