We are calling on the FDA to respond to our inquiry letter sent on August 19, 2019. This letter asked for FDA confirmation on the process for notifying consumers of new safety-related labeling changes that are constantly being released on the FDA's website. These new safety-related labeling changes pertain to FDA-approved medications, or drugs, currently being sold and marketed in the United States.

It's a fact - - every drug comes with a standard list of product information. Much of this material contains safety information and is made available to healthcare providers, but it can also be accessed by the general public. The problem is this information may not be readily available to the general public unless a person goes searching for it.

This product information contains critical details related to the safety of these drug products. Often, new safety risks are "discovered" on FDA-approved drugs which then requires this product information to be updated.

These safety-related labeling changes, or updates, commonly communicate new safety information on a particular drug. The new safety changes may be very important for a particular consumer to know, such as information on new black box warnings (the most serious safety warnings the FDA can require on a product label).

As such, it is paramount that any new safety risk information be communicated to consumers. Consumer awareness on new safety-related labeling changes may save a life. For example, consumers aware of these changes may be more proactive with the self-monitoring of their adverse drug reactions while on a certain medication (or) it may even prompt that consumer to initiate a conversation with their healthcare provider to discuss other alternative drug treatments that do not pose a particular serious or life-threatening safety risk.

However, consumers need to know in order to be able to make informed decisions and take the appropriate action. 

As shared in our letter to Dr. Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research, we reached out to the FDA back in July to confirm the process for notifying consumers about these new safety-related labeling change updates. Rather quickly, we received information from an FDA representative that any alerts to consumers would fall under the “practice of medicine”and be the responsibility of State Boards of Pharmacy or State Boards of Medicine.

The FDA representative also stated that the “FDA expects the new approved labeling will be available on the application holder’s Web site within 10 calendar days of approval of the labeling supplement, or FDA’s receipt of a changes being-effected labeling supplement. In addition, approved updates to labeling are posted on FDA’s Web site. 16 FDA acknowledges that incorporating labeling changes into printed material included in drug shipments usually requires more time than incorporating changes to a Web site.”

We appreciated the quick response from that FDA representative, but the comments were not conclusively clear on how or when consumers are actually informed.

It does not make sense that the FDA would hold authority to deem medications safe enough to be sold and marketed in America, but would not have a deeper awareness on how new critical safety information is then being communicated to the general public as new safety risks become known. Meanwhile, in our preliminary follow up on this matter with state Boards, we have not yet uncovered a single state in the U.S. that has a formal process of notifying consumers of these alerts (particularly in a timely fashion once the new safety risks are released on the FDA’s website).

The FDA and pharmaceutical companies are often the first to know about these important safety-related labeling changes since the two parties must coordinate together in order to ensure the proper information is added and communicated. However, consumers should know too - - or, at least as soon as that information is made available publicly. 

Relying on healthcare providers, who also may or may not be receiving timely notifications of these safety-related labeling changes, to provide this information directly to consumers presents with an inadequate strategy to protect public health and opens the door for huge variability and inconsistency from state to state (if states hold the sole legal responsibility for notifying consumers).

It also does not seem reasonable to assign the FDA's website as the primary (and potentially sole) source for consumers' awareness on safety-related labeling changes when some individuals will not be able to access the FDA's website due to reasons such as, limited internet access or difficulties with literacy. This is a passive communication approach. Americans need a more assertive one.

Therefore, Dr. Janet Woodcock, an FDA response would be appreciated. Please confirm the process for notifying consumers of safety-related labeling changes, from the FDA’s perspective. If the FDA is unaware of how consumers are being informed of these important safety-related labeling changes and/or there appears to be a gap in this consumer notification process, please acknowledge its existence so that efforts can be properly coordinated (either by the FDA or by other groups/organizations) for corrective action.  

American consumers know every drug comes with a number of potential safety risks and as these new safety risks are constantly emerging, even after a drug is FDA-approved, they deserve to be consistently and immediately notified about any new safety risks associated with the drugs in their medicine cabinet.

This is a public health matter. Let's address it.