The following is a brief written by LIVESTRONG‘s Director of Health Policy, Loyce Pace-Bass, explaining the recent U.S. drug shortage and what the White House, Congress, Federal Agencies, and advocacy groups like LIVESTRONG have done so far to address the shortage. There will be more information to come, but we want to make sure you are educated on current happenings surrounding this important issue.
The U.S. Drug Shortage:
What it is:
Since early this year, there has been increasing coverage in the media regarding a shortage of generic drugs in the U.S. Given generic drugs yield little profit compared to brand-name patented pharmaceuticals, there are few U.S.-based companies and limited competition among them. Therefore, when production slows or shuts down at one company, as has happened recently, there is little capacity or economic incentive for another company to step in and fill the gap, resulting in a net reduction of supply.
Why it matters:
Among the drugs in limited supply are those commonly used to treat a number of cancers. Patients and providers have reported delayed or revised chemotherapy and palliative care regimens as a result of drugs not being available at local hospitals. Aside from cancer, generic drugs are often used to treat infections, and also applied in ER or ICU settings as well as medical research protocols. In addition to affecting patient outcomes, the drug shortage is yielding a “grey market” that increases hospital costs.
The following is a review of recent government action in response to the U.S. drug shortage as well as our latest efforts:
The White House:
The President issued an executive order on Monday granting the Food & Drug Administration (FDA) and the Department of Justice (DOJ) authority to reduce and prevent drug shortages and their impact on the healthcare market as well as patients or providers. While only one aspect of the solution, the order calls for the following, also reflected in pending legislation:
- Broadening the reporting by industry corporations to the FDA regarding potential shortages of certain prescription drugs
- Speeding FDA reviews of applications submitted by other corporations to begin or alter production of these drugs; and
- Providing more information to DOJ about possible instances of collusion or price gouging (i.e. “gray market” practices).
The administration is also increasing human resources that will better equip the FDA to analyze root causes of drug shortages, liaise with manufacturers, review alternatives to address the problem, and implement other recommendations to track and respond to the crisis. Additionally, the government has released two reports that review underlying factors related to shortages and subsequent government strategies.
Members of the House and the Senate have introduced bills outlining new government authority and industry requirements. In general, proposed legislation calls for mandated reporting of potential drug shortages by industry corporations. The House bill further requires the FDA to publish information regarding shortages for patients, providers, and other stakeholders. It also calls for a study by the Government Accountability Office to examine supply chain, regulation, and communication processes, and recommend measures to improve them. Stakeholders have noted the limitations of pending legislation, and the bills’ sponsors have conceded that recommendations therein are only part of a more immediate solution. In addition to the bills, congressional committees have held official hearings on the drug shortage, which have included public testimony. However, with limited time remaining for congressional activities, it is unlikely that any legislative action will be taken before the end of this year.
The Department of Health & Human Services released 2 reports this week regarding the shortage. The Assistant Secretary for Planning and Evaluation has assessed the underlying causes that lead to shortages while the FDA has outlined a set of immediate and longer-term actions to address the issue. Some FDA recommendations include early notification (as called for by pending congressional legislation), data collection and analyses, enhanced quality assessments, more public disclosure, and market forecasting. However, no specific follow-up timeline is identified. The second report identifies as one of the root causes of the shortage a high demand for drugs that has been unmatched by manufacturing capacity.
LIVESTRONG signed a coalition letter supporting Senate legislation that would require companies to notify the FDA in advance of a drug not being available. Board Member Craig Nichols wrote a blog regarding the shortage and how it would have affected Lance had he been diagnosed today. We participated in government hearings and workshops on the issue. We will continue to partner with experts or other organizations to identify concrete solutions to the problem. A number of strategies have been proposed, including a national stockpile program and a non-profit that could import generics from other countries. Beyond federal regulation, financial incentives are needed to promote production of these essential medicines. For perspectives from our advisors, check out a blog by Dr. Hayes-Lattin from June 2011 and one by Dr. Craig Nichols from October.
According to the director of the FDA, there is still a need to hear from patient groups and other end-users so that regulators have an even clearer sense of the extent of the problem and solutions that can mitigate it in the future. LIVESTRONG created a scientific survey and is requesting those affected by the shortage to take part. We’ve already received a number of responses to the survey we developed which will be utilized for ongoing outreach, and are working with our partners at the Patient Advocate Foundation on a set of principles to inform additional advocacy efforts and recommendations. We also have participated in a number of multi-stakeholder sessions with partner coalitions, including Cancer Leadership Council and CEO Roundtable on Cancer. As this issue is evolving, we expect opportunities to engage in discussions and help develop solutions to continue into next year.
How can I help?
LIVESTRONG created the first formal survey for patients on the drug shortage issue. We invite all that have been affected to take the LIVESTRONG‘s Drug Shortage Survey. When you are done, please forward the link (http://www.surveymonkey.com/DrugShortage) to anyone you know that has been affected. Send it out to your healthcare providers so that they can distribute amongst their patients. Post it on your Facebook page or tweet out the link. Blog about your experience and include links to the survey. Share the survey with those in your support group. Make your voice heard!