FDA Needs To Do More To Prevent Food Shortages
June 2nd, 2022 // 5:24 pm @ jmpickett
In recent months, there has been a lot of attention devoted to the baby formula shortage gripping the US. Many in the regulatory industry have taken the FDA to task for not doing more to head off the problem sooner.
When it comes to regulating pharmaceuticals and medical devices, the FDA has dealt more effectively with shortages in the past. Ten years ago, FDA faced serious drug shortages, and there were many calls to address the issue in the media, as well as from health care providers.
In 2010, 75% of the drugs involved were sterile injectable products, which are especially important in a critical care setting. The media covered how difficult it was that doctors and patients didn’t have the drugs they needed to treat cancer. There also were shortages for critical care drugs and anesthetic agents.
There were many drug back orders that caused ill patients to get substitute drugs that made caring for them more expensive. The reason there were drug shortages in 2010 were similar to the baby food mess – manufacturing problems.
Of course, supply chain issues have always happened. Even before the pandemic, FDA dealt with many product shortages that were due to delays in getting raw drug ingredients and components from domestic and foreign suppliers.
One of the solutions to the drug shortages of the past was the FDA’s Drug Shortage Program that is part of CDER. The program was set up to deal with possible or real shortages of essential drugs that could affect public health. The Drug Shortage program partners with drug manufacturers, compliance, review divisions, and other FDA departments to deal with drug shortages.
For instance, when there is a shortage involved a generic drug, FDA works with other companies that make the drug to improve production if they can and want to. These companies may need FDA approval for new drug production activity or new drug ingredient sources to boost supply. FDA can expedite review to deal with shortages of drugs that are vital to patients.
The Drug Shortage Program also obtains reports from doctors, professional organizations, and patients. This program has 14 FDA employees, and there are fewer shortages today. When they happen, drug shortages are dealt with quickly.
But there is no such program involving foods in the US. This should change soon!
