On May 7, 2019, AHIP submitted a statement for a Senate Judiciary Committee hearing on “Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition.”
Our statement expresses support for the “CREATES Act” and the “Preserve Access to Affordable Generics and Biosimilars Act”—both of which take important steps to remove barriers to lower-cost generic drugs and promote competition in the pharmaceutical marketplace.
Other priorities we highlight in our statement include:
- Preventing the “evergreening” of patent protections—a scheme through which drug makers make minor changes to a drug’s chemical composition or delivery mechanism to extend patents that otherwise would have expired;
- Preserving the Inter Partes Review (IPR) process at the U.S. Patent and Trademark Office, which plays an important role in invalidating patents that do not represent true innovation and should not have been issued in the first place;
- Shortening the exclusivity period for biologics to promote greater price competition and help alleviate cost pressure for payers, patients and consumers for biologics; and
- Revisiting the incentives in the Orphan Drug Act to ensure that this law is used as intended by those developing medicines to treat rare diseases—not as a gateway to premium pricing and blockbuster sales and profits beyond orphan indications.