FDA, DEA Blame Manufacturers For Meds Shortage
FDA, DEA Blame Manufacturers For Meds Shortage
The important part:
The current shortage of stimulant medications is the result of many factors. It began last fall due to a manufacturing delay experienced by one drug maker. While this delay has since resolved, we are continuing to experience its effects in combination with record-high prescription rates of stimulant medications. Data show that, from 2012 to 2021, overall dispensing of stimulants (including amphetamine products and other stimulants) increased by 45.5 percent in the United States. According to a U.S. Centers for Disease Control and Prevention report, particularly during 2020-2021, when virtual prescribing was permitted on a widespread basis during the COVID-19 Public Health Emergency, the percentages in certain age groups grew by more than 10 percent. We are calling on key stakeholders, including manufacturers, distributors, pharmacies, and payors, to do all they can to ensure access for patients when a medication is appropriately prescribed. We want to make sure those who need stimulant medications have access. However, it is also an appropriate time to take a closer look at how we can best ensure these drugs are being prescribed thoughtfully and responsibly.
Stimulants are controlled substances with a high potential for abuse, which can lead to addiction and overdose. Therefore, there are limits (also known as quotas) set by DEA for how much of these drugs can be produced. However, for amphetamine medications, in 2022, manufacturers did not produce the full amount that these limits permitted them to make. Based on DEA's internal analysis of inventory, manufacturing, and sales data submitted by manufacturers of amphetamine products, manufacturers only sold approximately 70 percent of their allotted quota for the year, and there were approximately 1 billion more doses that they could have produced but did not make or ship. Data for 2023 so far show a similar trend.
We (DEA and the FDA) have called on manufacturers to confirm they are working to increase production to meet their allotted quota amount. If any individual manufacturer does not wish to increase production, we have asked that manufacturer to relinquish their remaining 2023 quota allotment. This would allow DEA to redistribute that allotment to manufacturers that will increase production. DEA is also committed to reviewing and improving our quota process.
Maybe, but my doctor and pharmacy both blame the DEA meddling for all the difficulties. No one wants to get their hand slapped and the regulations get stricter every year.
If your mom only gives you one candy per day, who are you going to blame the day your we’re not able to buy your candy because the store was out. If your mom allowed you to buy extra and save it for later it wouldn’t happen.
Maybe, but my doctor and pharmacy both blame the DEA meddling for all the difficulties.
Sure, because that's what they can see and what is relevant to them. They have no insight into the manufacturers allotment of production, what that production schedule is, or how much of their production allotment they've already used. What you're seeing in this article is "behind the scenes" look at just how deeply the US Government is involved in Healthcare.
And yet the DEA sets limits for manufacturing.
I am curious if the limitations are due to lobbying from the manufacturers to create an artificial limit to the supply.
I wouldn’t be surprised based on how these manufacturers have operated in the past.
Prescribing, manufacturing, sale, and use. The Government is watching and analyzing literally every link in the chain from the drug precursors to the patient.
Thank you for sharing this info. 12 days ago it took me, my doctor’s office, my insurance company, and 6 pharmacies to solve a 12 day supply to finish my original 28 day supply that was shorted. All those calls, sweat and tears still took 4 days to resolve. And now those 12 days are up. So now I’m in another battle to get this months prescription filled. It causes me so much anxiety, and feelings of hopelessness. I’m very grateful my doctor’s office called all these places on my behalf and advocated for me.
The key pieces of information missing from their numbers:
- What proportion of manufacturers hit a limit last year.
- If those allocations were adjusted this year to be given to mfgs that could actually produce.
- If they're talking about final product limits or core ingredient limits.
The DEA says that "manufacturers only sold approximately 70 percent of their allotted quota", but we don't get our medications from "manufacturers"; we get our medication from pharmacies, who often only carry 1 generic version of each medication in addition to the brand version. What percentage of generic manufacturers have hit their quota? My guess is that most of the slack is held by manufacturers of brand-name medication, while most of the limits are hitting manufacturers of generics.
Also, the "70 percent" stat is for "amphetamine products", but what is that referring to, exactly? Adderall? Vyvanse, which is an amphetamine prodrug? All stimulants? (It wouldn't surprise me, coming from the agency that likes to refer to all illegal drugs as "narcotics".)
This narrative that the FDA and DEA is pushing -- that manufacturers are somehow deciding not to make and sell medication that there is obvious demand for -- does not pass the smell test. Maybe the DEA quotas aren't to blame, but the notion that drug companies are deciding not to make and sell medication -- the one thing we've been able to count on them to do historically -- for some unknown reason that nobody is able to figure out is ludicrous.