The current status of drug availability has reached a crisis point, where ovarian cancer patients cannot receive standard therapies safely and on time. The Executive Order, signed by the President today, is only one step in addressing the widespread issue of drug shortages.
The Executive Order does not change the law, but directs the Food and Drug Administration (FDA) to use existing powers with the goal of reducing the impact and duration of shortages. The Executive Order reinforces that a sole manufacturer of a single drug must report intent to discontinue manufacturing six months in advance. The Order also includes mention of FDA’s power to expedite reviews of manufacturing sites, new drug suppliers and manufacturing changes when doing so would lessen the effect of a potential shortage. Lastly, the Order tells the FDA to communicate with the Department of Justice regarding stockpiling or price gouging related to these drugs.
Currently, many of the inexpensive standard treatments for ovarian cancer are not available; if women can get drugs, they may not meet the standard of care, they may not get drugs at the right time, or women may have to resort to more expensive or less effective drugs. This is an unacceptable situation.
The directions given to the FDA today will provide some help with a long term solution; however, they are no help to patients who cannot get their drugs today. Our patients require both long and short term solutions that provide access to safe and effective drugs. The Executive Order is within the current scope of the law, but does not meet immediate patient needs.
“We applaud the Administration’s efforts on this issue and look forward to continuing to work with all stakeholders towards a solution that meets the present and future needs of patients,” said Karen Orloff Kaplan, CEO of the Ovarian Cancer National Alliance. “Those needs are pressing.”