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 »

This morning the FDA added fluorouracil to its drug shortage list. The American Society of Healthcare Pharmacists (ASHP) has also reported a shortage of fluorouracil (5-FU), a common backbone drug for colorectal cancer chemotherapy.

Two manufacturers have some doses of the drug on intermittent back order and are shipping it as it becomes available.  A third has all dose vials on back order and estimates shipping sometime in the fourth quarter of 2011.

Read the rest of this entry »