FDA Takes its Fight Against Drug Shortages to the App Store
Drug shortages have been something of an endemic problem in the US for the last several years. For healthcare providers, it can be difficult to tell when a drug is in stock or experiencing a short- or long-term shortage. Now a new mobile application developed by the US Food and Drug Administration (FDA) is hoping to change that.
Background
FDA's struggles with drug shortages first emerged in 2011 and 2012, when many generic sterile injectable drugs began to experience supply shortages. While the roots of the problem are admittedly complex, various government investigations have identified five key causes for drug shortages:
- gray market pharmacies purchasing drugs experiencing low stock, and then reselling them at massive markups
- government reimbursement policies not allowing for prices to match market demand
- low profit margins causing companies to cease manufacturing older drugs in favor of newer, higher-profit-margin ones
- quality manufacturing problems experienced by many manufacturers of sterile products
- overly aggressive inspections by FDA
FDA now considers drug shortages to be a " top priority," and since 2012 it has taken several high-profile actions to try to help mitigate drug shortages:
- It has allowed the import of certain unapproved drugs to ease especially dire shortage situations.
- It has asked manufacturers to voluntarily notifyFDA of any impending supply problems or disruptions.
- FDA is working one-on-one with manufacturers to resolve problems that could result in supply disruptions.
- FDA has approved novel manufacturing agreements for some facilities to allow them to release some products for further processing or quality checks, a significant deviation from the usual quality-by-design parameters of current good manufacturing practices (CGMP).
- It has expedited the reviews of medications which can be substituted for a medicine experiencing a shortage.
- It has formulated a strategic plan on drug shortages, as required by Title X, Section 506D of the Food and Drug Administration Safety and Innovation Act (FDASIA).
- It has released a new rule requiring manufacturers to notify the agency of impending drug shortages.
- It has created a webpage to track all drug shortages.
A New Effort
Now FDA is taking its fight against drug shortages to the App Store.
On 4 March 2015, FDA announced that it would launch a mobile application "designed to speed public access to valuable information about drug shortages." The app will contain information about current drug shortages, resolved shortages and drugs scheduled to be discontinued.
Users can identify a drug by its generic name or by its active ingredient, but apparently not by its brand name. The app can also be used by healthcare providers and patients to report a suspected drug shortage to FDA.
The app is available for download on iTunes and the Google Play store.