We are constantly exploring actions the agency can take alone and in collaboration with other groups to reduce the impact and number of drug shortages. Health care professionals caring for patients need the right drug, for the right patient, at the right time. We want to ensure this important tenet of health care - and not having a product available can be a major road block to treatment. Until drug shortages cease to occur, we will continue to be vigilant in our efforts to prevent them.
There are a number of reasons why drug shortages can occur. Over half of all drug shortages are due to quality or manufacturing issues, such as the presence of particulates or endotoxins. Production delays at the manufacturer or delays obtaining raw materials and components from suppliers can all cause shortages.
Sometimes companies stop producing a drug to make newer, more profitable drugs. With fewer firms making sterile injectable drugs, there are fewer production lines and in this case a shortage can occur if even one of these lines becomes unavailable. Seven manufacturers produce most of the sterile injectable drugs on the market.
When one company has a problem or stops making the drug, it is difficult for the remaining companies to increase production quickly and shortages can occur. FDA cannot require a company to make a drug. But if a shortage is imminent, we can work with companies to try to minimize its impact. Early and open dialogue between FDA and manufacturers is critical to our success.
We have a carefully developed process we follow to identify the sources of the shortage and what can be done to prevent or minimize the impact of the shortage. To address the underlying causes, we work with the company to help resolve manufacturing or quality problems.
Per the FDA database, these ophthalmic drugs or products include staple items, such as fluorescein strips and solutions , dilation drops , glaucoma medications , antibiotics and antivirals. While many ophthalmic drugs entered shortage in only the past few months, some—fluorescein, specifically—have persisted for nearly two years. In January , doctors of optometry first alerted the AOA to a shortage of Fluorescein Sodium Ophthalmic Strips, and a call to the manufacturer confirmed the products on backorder with no availability among wholesale suppliers.
Although the company initially estimated a first-quarter release date, the specific fluorescein strips are still in shortage, now with an estimated availability of first-quarter At the time, the AOA reported the shortage to the FDA and noted the criticality of the shortage considering how routinely fluorescein strips are used in eye care providers' clinics and emergency departments.
Such reporting allows federal agencies to act on perceived or actual shortages, including but not limited to, movement of services and resources around in a strategic way that would benefit the community, Dr. Duenas notes. Forgot username or password? You do not have access to this content. Join the AOA today! FDA appreciates all information that manufacturers provide for posting on the FDA website since we realize how necessary this is for patients and healthcare professionals to be informed when shortages occur and how long they may last.
Manufacturers can report any information for posting to drugshortages fda. Are companies required to notify FDA of a potential drug shortage? A: Manufacturers are required to report information about shortages to FDA, and are required to report the reasons for shortages and the expected duration of shortages on the FDA website. Some of the enhanced authorities are as follows:.
When FDA takes an action such as sending a warning letter to a company or takes an enforcement action, is the shortage impact considered beforehand? When there are severe quality issues identified that could result in harm to patients, there may not be a way to avoid a shortage.
However, FDA does everything possible to work with firms to address any potential risks to keep medically necessary products available while also ensuring there is not going to be harm to patients associated with the quality issues. A: FDA is aware that there are drugs being marketed that have not received FDA approval but are medically necessary and have been marketed for many years.
When shortages occur for these drugs, FDA addresses these shortages through our normal processes and works with the companies to ensure patient needs are being met while also ensuring there is not any significant risk associated with the drug due to quality, safety, or efficacy that could result in harm to patients. FDA encourages the companies making these drugs to notify us of any changes in supply and also encourages the firms to seek FDA approval to help ensure ongoing quality and safety of these drugs for US patients.
Have FDA standards changed and companies can no longer meet those standards? A: FDA standards have not changed recently. The companies are responsible for ensuring that the drugs they make are manufactured in quality manufacturing sites so that US patients are not put at risk.
Why are there so many quality problems with drugs occurring recently? A: Problems can and do occur at any point in the manufacturing process and the manufacturing of sterile injectables is particularly complex and involves many steps where things can go wrong.
When problems occur at any step in the process, FDA encourages firms to notify FDA of any potential supply issues so we can help address the problem. Manufacturers are required to report discontinuances to FDA regardless of whether they intend to discontinue the product permanently or are facing only a temporary interruption of supply.
This program, within the Center for Drug Evaluation and Research CDER , was established to address potential or actual shortages of drugs that have a significant impact on public health. Through communication, facilitation and negotiation, DSS works with pharmaceutical manufacturers, review divisions, compliance and other components of FDA to manage product shortages. Who handles drug shortage issues in CDER? It consists of a dedicated staff of 11 scientific and regulatory experts who are responsible for the coordination of all activities related to the prevention and mitigation of drug shortages.
As the number of reports of drug shortages has increased, this staff has grown from 3 professionals to 11 in the past few years. The DSS coordinates with a host of other experts in CDER, which is estimated to utilize a total of about 25 full time employees, currently. Among other activities, the experienced and capable staff conduct medical necessity assessments, consider appropriate action on inspection reports and assess proposals of firms as they attempt to avoid supply disruption or increase production.
We expect that reports of potential and actual drug shortages will continue to increase in the next months to years, requiring that FDA allocate more resources to mitigate drug shortages in a timely manner to protect public health.
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