Cancer-drug shortages that have plagued U.S. hospitals are being targeted by Food and Drug Administration decisions, announced today, giving generic-drug makers clearance to provide stopgap replacements.
Use of the drugs Doxil, for treating ovarian cancer and multiple myeloma, and methotrexate, for leukemia and tumors of the breast and lung, will be bolstered by the decisions, the agency said. The cancer drugs are among 220 types of medications deemed to be in short supply in the U.S. by the American Society of Health-System Pharmacists.
Caraco Pharmaceutical Laboratories Ltd. will import an unapproved drug from India with the same active ingredient as Doxil, made by New Brunswick, New Jersey-based Johnson & Johnson, according to a letter on the agency’s website. A generic form of methotreaxate, made by APP Pharmaceuticals Inc., has received expedited approval from the agency and will be available in March, the FDA said.
Temporary importation of unapproved foreign drugs is considered “only in rare cases” when there is a shortage of a treatment “that is critical to patients” and can’t be resolved in a timely fashion with already approved drugs, the FDA said in the statement.
J&J alerted doctors in June about the Doxil shortage. The drug is produced by a contract manufacturer that signaled it would be getting out of the business over the next several years, according to Doxil’s website. J&J identified an alternative supplier and is transitioning over an extended period of time.
Caraco, a generic-drug maker based in Detroit, will temporarily import the drug Lipodox from its Mumbai, India-based parent, Sun Pharmaceutical Industries Ltd., the FDA said. Lipodox has the same active ingredient as Doxil and is made in a plant that has been inspected by the FDA, Sun Pharmaceutical said in a letter to doctors posted on the FDA website.
Supplies of methotrexate began running low last year when Boehringer Ingelheim GmbH in Ingelheim, Germany, shut its Ben Venue Laboratories factory in Ohio after manufacturing flaws there. Lake Forest, Illinois-based Hospira Inc., which also makes methotrexate, didn’t have the capacity to keep up with demand, Michael Ball, chief executive officer, said today. The company is expediting shipment of 31,000 vials, enough to meet one month of demand, to hospitals and clinics, the FDA said in the statement.
Hospira also will release another 34,000 vials next week that will meet the full market demand by mid-March and establish a safety stock, Ball said. Hospira was able to make the additional vials available by “scouring the globe” for FDA-approved active ingredient being used by other companies that make the medicine, Ball said.
President Barack Obama Oct. 31 directed U.S. regulators, through an executive order, to gather information from drug manufacturers about potential shortages.
The FDA has prevented 114 drug shortages since Obama signed the executive order, FDA Commissioner Margaret Hamburg said today. The agency released draft guidelines today that attempt to help drugmakers understand when they should notify regulators of an impending shortage.
Shortages of injectable cancer drugs such as Roche Holding AG’s Herceptin for breast tumors have created an opening for dangerous unapproved versions to be sold to clinics and other health-care providers, the FDA said last month. It warned providers to avoid direct solicitations from unproven sources and only buy drugs through approved channels.
In Congress, Democratic lawmakers including Senators Jay Rockefeller of West Virginia and Tom Harkin of Iowa and Representative Elijah Cummings of Maryland have pressed for probes of so-called “gray market,” or third-party drug resellers that some in the health-care industry have accused of price gouging.
Hamburg backed requiring drugmakers to notify the FDA of any interruption in production and giving the agency the ability to enforce the mandate. U.S. Representatives Diana DeGette, Democrat of Colorado, and Tom Rooney, Republican of Florida, have introduced legislation requiring notification, with daily fines of $10,000 for noncompliance.