FDA Commissioner Margaret Hamburg announced yesterday during a teleconference that the FDA has arranged to meet critical needs for methotrexate and Doxil® (doxorubicin).

FDA has approved temporarily importing Lipodox, which has the same active ingredient — doxorubicin — and the same concentration as Doxil. There should be enough to meet needs for Doxil treatment.  FDA has inspected and approved the foreign plants that manufacture Lipodox.

APP Pharmaceuticals and Hospira both have ramped up production of methotrexate. Together they expect to be able to ship the drug immediately and have enough to meet future needs.  Methotrexate is especially needed by children with leukemia where it can produce remissions rapidly and cure most children with acute lymphoblastic leukemia (ALL).

Unfortunately, fluorouracil (5-FU) and leucovorin are still in shortage. Read the rest of this entry »

President Barack Obama signed an Executive Order yesterday addressing the drug shortage issue.

As we have reported extensively on www.FightColorectalCancer.org, the current drug shortages have impacted colorectal cancer patients who have been unable to get 5-FU, leucovorin or on occasion, irinotecan.

The Executive Order does not change the law, and it will not help patients who cannot get their drugs today, but it does reinforce the powers of the Food and Drug Administration to take steps that would ease the burden by:

• Broader reporting of when a manufacturer has stopped producing a drug that could lead to a shortage.
• Increased effort to review drug suppliers and manufacturing sites and changes. It also directs the FDA to prioritize its resources according to the burden of the shortage to the public health.
• Collaboration with the Department of Justice to address drug stockpiling and price gouging.

The FDA has changed the package insert for Avastin® (bevacizumab) to include information about newly identified risks for the drug including

• Loss of ovarian function (ovarian failure).
• Bone death in the jaw (osteonecrosis).
• Bleeding and additional blood clots in patients who have already had a clot in their veins while on Avastin.

Changes to the Avastin label were announced on September 30, 2011. Read the rest of this entry »

If you missed the FDA Webinar on Drug Shortages last Friday, you can

Watch a video of the entire presentation, including questions.

Download the webinar slides.

The webinar, led by Captain Valerie Jensen, R.Ph., Associate Director for the FDA’s Drug Shortage Program, discusses how the FDA responds to drug shortages and what they are doing to try to prevent shortages of medically necessary drugs. Read the rest of this entry »

Drug shortages in the US are a growing crisis, members of Congress were told last Friday, September 23.  And there is no single reason why this is happening and no easy solutions to the problem.

Problems lie mostly in older generic versions of sterile injectable drugs, which are low-priced and

• complicated to manufacture
• made by a only a few companies
• manufactured in aging plants where quality is hard to maintain.

Read the rest of this entry »