Finding Federal Solutions…
Patients For Affordable Drugs is supportive of several reforms at the federal level that would lead to lower drug prices. Candidates at the federal level should be encouraged to support the following policy ideas:
Allow Medicare Negotiation and use of value-based pricing: Right now Medicare cannot bargain directly with drug companies. The result is that patients in the U.S. pay two-three times more than patients in other nations. We should develop a system that incorporates an independent analysis of value to the patient as one component in establishing drug prices. Using this measure and others, we need to use our collective purchasing power –– as other nations do –– and give Medicare the authority to negotiate directly with drug corporations.
Introduced legislation: S.2011/H.R.4138 Medicare Drug Price Negotiation Act
End Patent Abuse: Brand drug manufacturers abuse the patent system through a variety of tactics that protect their monopoly pricing power and prevent cheaper generics from coming to market. These patent abuses must be stopped.
Deals-For-Delay: Brand name drug companies pay off generic companies who plan to bring a competitor to market, in exchange for the generic manufacturer delaying its entry into the market. This practice should be outlawed.
Introduced legislation: S.124 Preserve Access to Affordable Generics Act, S.2476 Expanding Access to Low Cost Generic Drugs Act
REMS abuses: Brand name companies use a program called Risk Evaluation and Mitigation Strategies (REMS) as a pretext for not selling generic companies samples of their drug in order for the generic company to create a lower-priced competitor. The US could save $3.8 billion by stopping this abuse which the FDA has called “unfair and exploitive.”
Introduced legislation: S.194/H.R.2212 CREATES Act
Evergreening: Drug companies make tiny changes to their drug, such as moving from a tablet to a capsule, and patent the new product in order to extend their monopoly and keep control of price. This gaming of the system should not be permitted.
Patent-thickets: Brand drug companies often file dozens of new patents on old drugs in order to force a generic company to file suit against each of them, which delays the generic from coming to market by years. A recent report found that 75 percent of patents are filed on old drugs instead of new, innovative drugs that improve people’s lives.
Sham Citizen petitions: Citizen petitions can be filed at the Food and Drug Administration requesting FDA action. But brand-name drug makers filed 92 percent of all citizen petitions between 2011 and 2015 aimed at blocking cheaper generic drugs. The FDA denied more than 9 of every 10 those petitions. We should stop the use of sham citizen petitions.
Renting sovereign immunity: One brand name company sold the patent for its drug to an American Indian tribe which has sovereign immunity in some legal proceedings. The move was designed to prevent drug patent review and block generic entry. Courts have not allowed this practice to stand, but appeals may continue. Congress needs to outlaw this effort to circumvent the law once and for all.
Introduced legislation: S.2514 PACED Act
Require Pharmacy Benefit Manager Transparency and eliminate rebates: Pharmacy Benefit Managers –– the drug middlemen supposed to operate on behalf of patients –– are a black box. They receive rebates and other forms of payments from drug manufacturers as they process prescription drugs. But it is unknown to what extent their practices keep drug prices high or how much of the benefit of rebates reaches patients and consumers.
Introduced legislation: S.637 C-THRU Act, H.R.1316 Prescription Drug Price Transparency Act
PBMs also engage in anti-consumer practices called gag clauses which prohibit a pharmacist from informing a consumer about the lowest price option. Congress should prohibit gag clauses in deals with insurers and pharmacies.
Introduced legislation: S.2553 Know the Lowest Price Act of 2018, S.2554 Patient Right to Know Drug Prices Act
Demand Drug Pricing Transparency: Pharmaceutical corporations should be required to disclose price increases above a certain amount and the inputs behind them. Such required reporting should include:
Research and development costs
Cost of production
Marketing and advertising costs
Yearly profit on the drug
Introduced legislation: S.1131 Fair Accountability and Innovative Research Drug Pricing Act of 2017