FDA Head Says Drug Shortages ‘Out of Our Control’
/By Pat Anson, PNN Editor
With drug shortages in the U.S. near record levels, the head of the Food and Drug Administration says there is little his agency can do to ease shortages, particularly those involving generic drugs.
“We wish that we could fix all these things, but we don't make the medicines and we can't tell someone that they must make medicines. There are some things that are out of our control,” FDA Commissioner Robert Califf, MD, said in an interview with Medscape.
There are currently 207 medications in short supply, according to the FDA’s drug shortage list, but the American Society of Health-System Pharmacists (ASHP) has a much higher estimate of over 300 active drug shortages, the most since 2014.
Shortages of generic medications used to treat cancer and attention deficit disorder (ADHD) have gotten the most attention, but there are also emerging shortages of generic oxycodone and other opioid pain medications. About 90% of prescribed drugs in the U.S. are low-cost generics.
“And this has caused a big problem, where a number of generic drugs are in shortage at any given time, because there's not enough profit for a company to say they want to go into the business of making that drug,” said Califf.
Teva Pharmaceutical, one of the world’s largest manufacturers of generic drugs, announced last month that it would change its business model to focus on more profitable branded drugs. Teva has already informed the FDA that it was discontinuing production of 30, 15, and 5 mg tablets of generic oxycodone.
Another generic drug maker, Perrigo Pharmaceuticals, recently notified the FDA that it was stopping production of a cough syrup made with hydrocodone.
Pain patients have had trouble for years getting prescriptions filled for opioids, but the problem appears to have gotten more acute in recent months – and not just for generic opioids. Joy CobbWilliams told PNN she has trouble getting prescriptions filled for OcyContin, a branded formulation of oxycodone that she’s been taking for nearly a decade for chronic back pain.
“Month after month I run out of my medication while I wait for the pharmacy to get more. Some months I wait three or four days and other months I wait almost two weeks. The pain I suffer is unbearable,” she said. “Something needs to be done. We have got to do better for the patients suffering and not abusing the medication. This is the United States and there should be no reason someone suffering should have to wait days to weeks to get their 10mg OxyContin.”
Kim Luarks told us she’s had problems with her pharmacy running out of fentanyl patches and Xtampza ER (oxycodone). She’s been on opioids for 20 years due to chronic back pain.
“Here I sit, still waiting and have been without any long-acting opioid for (7 days) and not feeling too hot,” she said. “This could be detrimental to my life, let alone my heart and lungs that are already damaged due to the doctors just throwing pain meds at me in the early 2000’s. I've been through all the changes and federal regulations causing this nonsense.”
The Drug Enforcement Administration, in consultation with the FDA, determines the annual production quotas for opioids and other controlled substances. Despite Califf’s contention that drug shortages are “out of our control,” it was the FDA that advised the DEA that demand for Schedule II opioids such as oxycodone would fall by 5.3% in 2023.
DEA adopted the FDA’s recommendations and reduced the supply of opioids for the seventh consecutive year, saying it would be “sufficient to meet all legitimate needs.” Since their peak in 2013, DEA production quotas have fallen by 65% for oxycodone and 73% for hydrocodone.
In his interview with Medscape, Califf suggested that some medications are now in short supply not because of production quotas, but because they are prescribed to people who don’t really need them. He said stronger medical guidelines may be needed to discourage doctors from overprescribing.
“If only the people that needed these drugs got them, there probably wouldn't be a shortage. There's a large amount of use which is on the margins. And this is why I say we need better clinical standards,” Califf said.
“But having said all that, we're working with the DEA frequently as they try to work out what the quotas are. And we're working with the companies to optimize production. So that shortage should go away. It's better now than it was a few months ago, and it's going to continue to get better.”
