This bill, sponsored by Sen. Susan Collins (R-ME) and co-sponsored by Sen Claire McCaskill (D-MO) and Sen Jon Tester (D-MT), is intended to speed up review for generic drug applications under certain conditions. These conditions include: when there are drug shortages, when there is only one manufacturer of a drug or when tentative approval has been granted to not more than two applications.
The findings of the bill include a reference to the enormous price hikes of some off-patent drugs that have made headlines in recent months. Specifically:
(7) The sudden, aggressive price hikes for a variety of recently acquired off-patent drugs that have been used widely for decades, for which there is no generic drug competitor, also affects access to affordable prescriptions for patients and the overall cost of health care in the United States.
Martin Shkreli, this section is directed at you – and a few others as well.
The bill requires that the FDA to prioritize the review of and act not later than 150 calendar days after the date of the submission of an application, on an application that has been submitted for review under this subsection, or on a supplement to such an application, is for a drug that -
(i) has been introduced into interstate commerce by not more than one manufacturer or sponsor, as applicable, in the last 3 months and with respect to which tentative approval under paragraph (5) has been granted for not more than 2 applications; or
(ii) has been included on the list under section 506E.
The bill, if passed, should benefit patients. However, it might give some investors (and M&A analysts) pause. Companies that have taken advantage of situations where drugs are off-patent but have no competitors may find their ability to squeeze enormous profits from the drugs short-lived.
You can read the complete text of the bill here: https://www.govtrack.us/congress/bills/115/s297/text