On February 6, 2018, UACT and 43 other organizations sent a letter to leaders in Congress, urging them to increase patients access to generic drugs by passing the CREATES Act.
When the FDA registers a brand name drug, it sometimes requires the manufacturer to submit a risk management strategy (called REMS), containing a plan for how the drug will be managed in order to ensure that the benefits to patients outweigh the potential risks of side effects or adverse outcomes. These protocols can include restrictions on how and to whom the drugs can be distributed, for example saying that a drug can only be dispensed in a healthcare setting with access to emergency supplies to assist in the event of side effects. These protocol are required in drugs such as Prolia, which can treat bone cancer, Revlimid for lymphoma, or Blincyto for leukemia.
These restrictions can cause delays when trying to create generic drugs or biosimilars. When a company wants to register a generic version of a drug, they have to test it against the brand name version, which means that they need a sample of the brand name. Pharmaceutical companies have used the risk management protocol as an excuse to not give generics manufacturers samples of the drugs they need. In November, FDA Commissioner Scott Gottlieb referred to the abuse of loopholes like this as “shenanigans”, and urged drug companies to stop this behavior.
The CREATES Act would give generic manufacturers an avenue to sue brand-name drug manufacturers when samples aren’t provided. Manon Ress of the Union for Affordable Cancer Treatment, explained the organization’s support for this legislation:
“Patients have been waiting for this Congress to take action and lower drug prices. Anything that would accelerate generic access to the best drugs available and lower prices through competition is welcome by patients. UACT has signed this letter with hopes that Congress will finally act fairly, in the interests of patients and not just in the interest of pharmaceutical companies.”