Drug & Device News

To Address Shortages, FDA Allows Import of Unapproved Cancer Drugs

Responding to concerns that supplies of certain cancer treatment drugs had become dangerously short, the U.S. Food and Drug Administration (FDA) took steps in February to address the crisis; the agency temporarily authorized the import of two unapproved medications. The FDA announced it would allow the importation of the drug Lipodox (doxorubicin hydrochloride liposome injection), manufactured by India's Sun Pharma Global, to replace Doxil (doxorubicin hydrochloride liposome injection). Doxil, which is commonly used to treat certain ovarian cancer patients and patients with AIDS-related Kaposi's sarcoma or multiple myeloma, became scarce after the drug's manufacturer shut down production at its Ohio facility late last year. The FDA, which in rare emergency circumstances allows the importation of unapproved drugs that are critical to patients, expects the Lipodox imports to meet all U.S. patient needs.

In addition to Doxil shortages, the currently inadequate supply of another cancer treatment drug, methotrexate, is being addressed by the FDA with expedited approval of a new U.S. manufacturer of the medication. Until that source can take up the slack, temporary imports of unapproved methotrexate from an Australian manufacturer will be permitted to ease the immediate shortage.

In announcing these measures to bolster the supply of crucial cancer treatment drugs, FDA Commissioner Margaret A. Hamburg, M.D., said, “A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration. Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.”

Warning: Dental X-Ray Devices Purchased Online May Be Unsafe

Dental and veterinary professionals are being warned not to purchase or use hand-held dental X-ray units purchased online from overseas sellers because they have not been tested by the FDA for safety. It is feared that these units may expose patients to harmful radiation levels, although no adverse events have yet been reported. “Health care professionals using these devices should verify they are purchasing and using those that have been reviewed and tested to meet FDA's standards,” said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health. Any hand-held dental X-ray device that has been deemed safe by the FDA will have a permanent certification label, a warning label, and an identification label.

CA High Court to Review 'Pay for Delay'
Pharmaceuticals Settlement

The California Supreme Court on Feb. 15 said it will consider a challenge, brought by a class of consumers, to the type of pharmaceutical patent lawsuit settlements known as “pay for delay.” The review comes following an appeals court endorsement of a $398.1 million payment Bayer AG, owner of the patent on the antibiotic Cipro, gave to Barr Laboratories and other competitors to induce them to delay the introduction of their own generic versions of the drug. The plaintiffs allege agreements like that in In re Cipro Cases I & II violate antitrust laws, as their only purpose is to eliminate competition and permit the patent holder to continue to keep prices of their pharmaceutical products high. Pharmaceuticals companies see the issue differently, claiming there is nothing illegally anti-competitive about pay-for-delay agreements so long as they do not extend the competition's sales restrictions beyond the period of the exclusive patent.

Despite Warning Label, Discovery Rule Permits Late-Filed Accutane Suit to Proceed

On Feb. 27, justices in the case of Kendall v. Hoffman-LaRoche Inc., A-73-10, rejected drug manufacturer Hoffman-LaRoche's attempt to have an Accutane user's case thrown out for late filing. The drug company unsuccessfully argued that FDA-approved warning labels, as well as defenses provided by New Jersey's Products Liability Act, barred the use of the “discovery rule,” which extends the time in which a plaintiff may bring her suit by starting the clock from the time a causal link between an injury and its cause is discovered, instead of from the time that the injury occurred. While the court agreed with the manufacturer that an FDA-approved warning of possible adverse effects of a drug will usually prevent a plaintiff from claiming late discovery of a causal connection between a drug's use and a known side-effect, that rule has exceptions. In Kendall, the injured Accutane user had begun taking the drug at her doctor's recommendation when she was just 12 years old, and there was strong evidence that she never saw or was told of the warning that the drug was linked with the development of irritable bowel disease (IBD). Plaintiff Kamie Kendall began using Accutane in 1997, took several courses of it over a period of years, and in 1999 developed such a bad case of ulcerative colitis (a form of IBD) that she had to have her colon removed in 2005. The plaintiff discovered the causal link between her illness and her Accutane use in 2003 and filed her suit on Dec. 21, 2005.

To Address Shortages, FDA Allows Import of Unapproved Cancer Drugs

Responding to concerns that supplies of certain cancer treatment drugs had become dangerously short, the U.S. Food and Drug Administration (FDA) took steps in February to address the crisis; the agency temporarily authorized the import of two unapproved medications. The FDA announced it would allow the importation of the drug Lipodox (doxorubicin hydrochloride liposome injection), manufactured by India's Sun Pharma Global, to replace Doxil (doxorubicin hydrochloride liposome injection). Doxil, which is commonly used to treat certain ovarian cancer patients and patients with AIDS-related Kaposi's sarcoma or multiple myeloma, became scarce after the drug's manufacturer shut down production at its Ohio facility late last year. The FDA, which in rare emergency circumstances allows the importation of unapproved drugs that are critical to patients, expects the Lipodox imports to meet all U.S. patient needs.

In addition to Doxil shortages, the currently inadequate supply of another cancer treatment drug, methotrexate, is being addressed by the FDA with expedited approval of a new U.S. manufacturer of the medication. Until that source can take up the slack, temporary imports of unapproved methotrexate from an Australian manufacturer will be permitted to ease the immediate shortage.

In announcing these measures to bolster the supply of crucial cancer treatment drugs, FDA Commissioner Margaret A. Hamburg, M.D., said, “A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration. Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.”

Warning: Dental X-Ray Devices Purchased Online May Be Unsafe

Dental and veterinary professionals are being warned not to purchase or use hand-held dental X-ray units purchased online from overseas sellers because they have not been tested by the FDA for safety. It is feared that these units may expose patients to harmful radiation levels, although no adverse events have yet been reported. “Health care professionals using these devices should verify they are purchasing and using those that have been reviewed and tested to meet FDA's standards,” said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health. Any hand-held dental X-ray device that has been deemed safe by the FDA will have a permanent certification label, a warning label, and an identification label.

CA High Court to Review 'Pay for Delay'
Pharmaceuticals Settlement

The California Supreme Court on Feb. 15 said it will consider a challenge, brought by a class of consumers, to the type of pharmaceutical patent lawsuit settlements known as “pay for delay.” The review comes following an appeals court endorsement of a $398.1 million payment Bayer AG, owner of the patent on the antibiotic Cipro, gave to Barr Laboratories and other competitors to induce them to delay the introduction of their own generic versions of the drug. The plaintiffs allege agreements like that in In re Cipro Cases I & II violate antitrust laws, as their only purpose is to eliminate competition and permit the patent holder to continue to keep prices of their pharmaceutical products high. Pharmaceuticals companies see the issue differently, claiming there is nothing illegally anti-competitive about pay-for-delay agreements so long as they do not extend the competition's sales restrictions beyond the period of the exclusive patent.

Despite Warning Label, Discovery Rule Permits Late-Filed Accutane Suit to Proceed

On Feb. 27, justices in the case of Kendall v. Hoffman-LaRoche Inc., A-73-10, rejected drug manufacturer Hoffman-LaRoche's attempt to have an Accutane user's case thrown out for late filing. The drug company unsuccessfully argued that FDA-approved warning labels, as well as defenses provided by New Jersey's Products Liability Act, barred the use of the “discovery rule,” which extends the time in which a plaintiff may bring her suit by starting the clock from the time a causal link between an injury and its cause is discovered, instead of from the time that the injury occurred. While the court agreed with the manufacturer that an FDA-approved warning of possible adverse effects of a drug will usually prevent a plaintiff from claiming late discovery of a causal connection between a drug's use and a known side-effect, that rule has exceptions. In Kendall, the injured Accutane user had begun taking the drug at her doctor's recommendation when she was just 12 years old, and there was strong evidence that she never saw or was told of the warning that the drug was linked with the development of irritable bowel disease (IBD). Plaintiff Kamie Kendall began using Accutane in 1997, took several courses of it over a period of years, and in 1999 developed such a bad case of ulcerative colitis (a form of IBD) that she had to have her colon removed in 2005. The plaintiff discovered the causal link between her illness and her Accutane use in 2003 and filed her suit on Dec. 21, 2005.