FDA approves emergency importation of cancer drugs to ease shortage
The Food and Drug Administration has approved temporary drug importations of Doxil to ease the critical shortage of the generic cancer drug commonly used to treat ovarian cancer.
The agency also announced that several drug manufacturers are boosting production of methotrexate – a generic injectable drug used to treat breast cancer, lung cancer, and leukemia – to prevent a supply shortfall this year.
“A drug shortage can be a frightening prospect for patients,” said FDA Commissioner Margaret Hamburg, M.D. “Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability shoal now be able to get the medication they need.”
Last summer, Johnson & Johnson reported manufacturing delays in the production of Doxil (doxorubicin hydrochloride liposome injection), which is used to treat ovarian cancer, AIDS-related Kaposi sarcoma (cancer that grows under the skin), and multiple mylemoa (bone marrow cancer). The production delay was expected to last several months, and doctors were advised to seek alternative treatments as the supply of Doxil dwindled.
“Without access to the preferred drug treatment, clinicians must use alternatives, which may be less effective or associated with increased risk of adverse outcomes,” said Dr. Kasey Thompson, Vice President of Policy for the American Society of Health-System Pharmacists, during a Senate hearing on drug shortages in December.
With Doxil supply approaching a critical low, the FDA reached out to other pharmaceutical companies to help end the shortage. As a result, Caraco Pharmaceutical Laboratories Ltd. has agreed to import replacement supplies of doxorubicin hydrochloride liposome injection – sold under the name Lipodox – manufactured by Sun Pharma Global FZE.
Although Lipodox has not been formally approved for sale in the United States, Sun Pharma’s production facility in Halol, India holds FDA approval and produces other generic drugs that are sold in the U.S. In addition, the FDA has evaluated Lipodox to ensure its quality and safety before approving the temporary importation.
“Temporary importation of unapproved foreign drugs is considered in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs,” the agency explained in a statement. “FDA anticipates that the incoming supply of Lipodox will be able to fully meet patient needs.”
Preventing shortage of methotrexate
Following the Doxil shortage, President Barack Obama issued an executive order requiring pharmaceutical manufacturers to notify the FDA of discontinuances of critical, life-saving drugs. Given advance notice, the FDA can work with other pharmaceutical manufacturers and distributors to prevent or lessen the impact of potential drug shortages. The order also authorized the FDA to fast-tack regulatory approval for drugs that are in short supply. Since the order was issued in October 2011, the agency has prevented 114 drug shortages.
The FDA has worked with several generic drug manufacturer to increase supply of preservative-free methotrexate, which is used to treat children with acute lymphocytic leukemia (ALL).
Since Bedford Laboratory suspended production at its Ben Venue facility three months ago due to manufacturing issues, many hospitals and doctors have trouble obtaining adequate supply of methotrexate.
To increase the supply of the cancer drug, the FDA has expedited and approved APP Pharmaceutical’s application to produce preservative-free methotrexate. APP is expected to start shipping the drug next month.
Another manufacturer, Hospira, has agreed to ship 31,000 vials of the drug starting today, which would meet the nationwide demand for about a month.
The agency is also working with Mylan and Sandoz Pharmaceuticals to increase production of methotrexate.
In addition, Bedford Laboratory is releasing a limited supply of methotrexate produced prior to Ben Venue’s shutdown.
Pending legislations to drug shortage notification
Two bills to address the drug shortage problem were introduced last year:
- H.R. 2245 “Preserving Access to Life-Saving Medications Act of 2011” sponsored by Rep. Diana DeGette (D-Colo.)
- S. 296 “Preserving Access to Life-Saving Medications Act” sponsored by Sen. Ann Klobuchar (D-Minn.)
In the meantime, the FDA has issued new guidelines on mandatory and voluntary reporting of disruptions that could cause a drug shortage.
- FDA.gov: FDA acts to bolster supply of critically needed cancer drugs
- FDA.gov: Current drug shortages
- FDA.gov: Guidance for industry notification to FDA of issues that may result in a prescription drug or biological product shortage (PDF)
- WhiteHouse.gov: Executive Order 13588 – Reducing prescription drug shortages
- Thomas.LOC.gov: S. 296 “Preserving Access to Life-Saving Medications Act”
- Thomas.LOC.gov: H.R. 2245 “Preserving Access to Life-Saving Medications Act of 2011”
- NIH.gov: Information on Methotrexate
- NIH.gov: Information on Doxil
- Jansenn Products, LP (owned by Johnson & Johnson): Letter to health care providers on Doxil shortage (PDF)
- Ben Venue Laboratories
- Sun Pharma Global FZE
- Caraco Pharmaceutical Laboratories Ltd
- WhatTheFolly.com: Transcript: Testimony of Dr. Kasey Thompson on drug shortages
- Transcript: Sen. Max Baucus’ opening statement on drug shortages
- Transcript: Sen. Orrin Hatch’s opening statement on drug shortages
- Transcript: Testimony of Dr. Kasey Thompson on drug shortages
- Transcript: Testimony of Dr. Patrick Cobb on drug shortage
- Transcript: Testimony of Dr. Scott Gottlieb on drug shortages
- Transcript: Testimony of Dr. Rena Conti on drug shortages
- Transcript: Drug shortages Q&A by Sen. Orrin Hatch
- Transcript: Drug shortages Q&A by Sen. Jeff Bingaman
- Transcript: Drug shortages Q&A by Sen. John Cornyn
- Transcript: Drug shortages Q&A by Sen. Ron Wyden
- Transcript: Drug shortages Q&A by Sen. Ben Cardin
- Transcript: Drug shortages Q&A by Sen. John Thune
- Transcript: Drug shortages Q&A by Sen. Chuck Grassley
- Transcript: Drug shortages Q&A by Sen. Tom Carper
- Senate Committee on Finance: Hearing on “Drug Shortages: Why They Happen and What They Mean” held on Dec. 7, 2011 (video)