Drug Shortages: Transcript
We’re at the U.S. Food and Drug Administration with the Division of Drug Information pharmacists. Today, they are discussing FDA’s role in mitigating drug shortages. This is FDA Drug Info Rounds, a program by pharmacists for pharmacists.
This week we received an email from a pharmacist who is very upset about drug shortages. He believes that FDA decides when a company discontinues manufacturing and marketing of a drug.
I’m not sure people always understand that FDA doesn’t manufacture or distribute drugs, and in almost all cases we don't control if or how much drug is manufactured, distributed or kept in inventory.
It sounds like the misunderstanding may lie more than just with some pharmacists, so we should be clear. When manufacturers decide to discontinue making or marketing a drug, it’s often because of business reasons. It’s important for pharmacists and consumers to know that FDA generally does not have the authority to require a company to continue making a medication. If, however, a drug is considered medically necessary, and a shortage would occur if a company decided to stop making a medication, FDA can look for alternative manufacturers and work with them to make sure there is an adequate supply of the drug on the market.
It may be helpful for pharmacists to understand FDA’s definition of “medically necessary.” FDA defines a drug as medically necessary if the drug is used to prevent or treat a serious or life-threatening disease or medical condition, for which there is no other available source with sufficient supply of that drug or alternative drug available.
Fortunately, manufacturers often notify FDA, usually through our Drug Shortages Team, about potential or current shortages, although they are not required by law to do so.
Drug shortages can occur for many reasons, such as: a manufacturer’s inability to obtain raw materials; manufacturing problems which stop or delay the production of a drug; and sometimes it’s a business decision made by a manufacturer to discontinue a drug.
FDA established the Drug Shortages Program to take action on drug shortages that have a significant impact on public health. Over the past two years the program has expanded due to the increasing number and complexity of drug shortages.
FDA can address drug shortages by: working with manufacturers to resolve issues that enable medications to return to the market; expediting FDA’s process for drug applications under review to help get product to market as soon as possible; and helping manufacturers identify new sources of raw material.
Some community pharmacies and hospitals experience a drug shortage due to contractual agreements with a specific distributor or manufacturer, even though alternative drugs may be available. This is not the same as an FDA identified drug shortage and it is not within FDA’s regulatory authority to address these contractual issues. Nevertheless, if a pharmacy is having difficulty obtaining a drug, the Drug Shortages Team can be contacted for guidance, and perhaps provide information on the availability of an alternate source.
Sometimes shortages create potential safety issues. FDA does not typically invest resources into shortages that are expected to be temporary and self-limiting, or those involving only a specific strength or package size of a drug, because of finite resources and the transient nature of these types of shortages. However, in some cases, there may be an increased risk of medication errors with use of alternate strengths or packaging of drugs in short supply. In these cases we prioritize shortages based on the potential for safety.
While manufacturing issues remain an important cause of drug shortages and the cause most amenable to FDA assistance, other factors contribute to the issue. A significant factor in the development of many shortages is related to the number of manufacturers producing a specific drug and their respective shares of the market. For example, few companies have the capability to produce sterile injectable drugs. Therefore, injectable drugs are especially susceptible to shortages.
In addition, FDA cannot require manufacturers to provide notification when they make a decision to stop making a drug, unless it’s a sole-source drug used to treat a serious disease or medical condition.
As we noted earlier, although in most cases the FDA does not have the authority to require a manufacturer to produce a drug, the agency can encourage a manufacturer to produce a drug in short supply by expediting the review of data supporting a new or generic drug application for the same drug made by another manufacturer.
Remember the erythromycin ophthalmic ointment shortage? Because this was considered a medically necessary drug and in short supply, the Generic Drugs Office expedited its review of data to support approval of a generic drug application. This was a tremendous help in resolving that shortage.
Another way FDA can help alleviate shortages is to use this authority to temporarily approve the use of drugs approved in other countries for use here in the U.S. Recent examples include propofol and ethiodized oil. With these drugs in short supply, FDA identified overseas versions that meet FDA’s safety, efficacy and quality standards, and temporarily permitted importation to help supply the U.S. market until the shortage was resolved.
That’s true Leslie; and, if a new manufacturing site needs to be added because of problems or limitations at the existing site, or if a new supplier must be added, FDA’s review of data to support these changes can be expedited for medically necessary drugs, too. When a drug is in shortage, alternative drugs may be identified by the FDA.
Another example of FDA’s efforts to help manufacturers facing a supply shortage is to assist them in instituting an allocation program to limit distribution of the remaining inventory until the shortage issues are resolved. In some cases, an allocation program may be initiated to help ensure that a drug is available for patients on an emergency-only basis for life-threatening conditions, for which no alternative therapy exists. This helps to more evenly distribute supplies.
The Drug Shortages Team looks at all available options, including the potential for unapproved or off label uses of a drug, as well as whether a reasonable alternative drug exists in adequate supply.
Once the Drug Shortages Team verifies a shortage and confirms that it is not transient or self-limiting, the responsible review division that has the requisite scientific and medical expertise regarding the drug is notified and consulted to determine whether the drug is medically necessary.
Yes, and if the drug is deemed medically necessary, it’s FDA’s policy to attempt to prevent or alleviate a shortage as best we can - given our legal authorities.
FDA’s website provides information about shortages and limited distribution of medically necessary drugs. It includes information about the specific drug, the reason for the shortage, and the manufacturer’s anticipated date of availability. FDA is reliant on the information reported to us by manufacturers. If there is information posted on our website that is not consistent with what pharmacies are experiencing, that should be conveyed to the Drug Shortages Team. That way, they can check again with the manufacturers on the accuracy of reporting.
It’s important to note that FDA does not have the authority to require manufacturers to provide public information about shortages for posting; however, we ask them to do this voluntarily, since we know this information is needed by healthcare professionals and patients.
Early notification of potential or actual shortage issues enables the shortage to be addressed more quickly and may even prevent the shortage from worsening or occurring in the first place. FDA is committed to working with manufacturers to do everything within our legal limits to sustain levels of production that will provide adequate amounts of drug to patients who depend on them.
Thanks for joining the FDA pharmacists at their Drug Info Rounds. This is our FDA program of pharmacists helping pharmacists educate consumers, so they can make better medication choices.
If you have questions or information about drug shortages, email FDA’s Drug Shortage team at firstname.lastname@example.org.
And finally, if you have general drug information questions, you may reach FDA’s Division of Drug Information by calling 1-888-463-6332, or email us at email@example.com.