Product Shortages’ Prominent Place on FDA’s Agenda

During the Alliance webinar with Commissioner Califf on August 22, he said: “I didn’t come back to FDA to spend my time on shortages (but that’s what has happened).”

Product shortages represent a visible and concerning problem that affects many people and businesses. However, it was revelatory to me that it takes up so much of the Commissioner’s time.

Addressing product shortages is neither a traditional responsibility of FDA nor primarily a regulatory problem. FDA has become involved because it must—shortages have serious repercussions. In many instances only FDA, working with other government agencies and the private sector, can assure 1/ public and personal health, 2/ patient and consumer safety, and 3/ equity in the distribution and availability of products in shortage.

Drug shortages are most often cited, but there can be shortage problems across the entire range of FDA-regulated products—biologics, vaccines, medical devices, laboratory tests, food, and animal products.

FDA cannot turn away from this responsibility nor minimize it. Every shortage reflects different circumstances, different dynamics, and different root causes. Blunt tools are often the only remedy FDA has to address highly nuanced situations. Even then, solutions usually require a degree of voluntary cooperation from parties over whom FDA has limited or no authority.

There are two types of shortages that require different responses. Supply-side shortages reflect level demand for a product with an inability of the marketplace to supply sufficient amounts. In contrast, demand-side shortages occur when production is otherwise sufficient, but there is a sudden unexpected need for additional product (e.g., a contagious disease outbreak requiring additional vaccine supplies). This distinction is just a starting point for understanding the root causes and the need for individualized and customized responses.

A constant theme for the Alliance is that FDA’s mission and responsibilities increase each year. Product shortages are just one example, but an important one. In this case, the demand for FDA involvement comes not from legislation or regulatory needs, but from market failures to which only FDA can coordinate the public and private response.

So, why is this area commanding so much of the Commissioner’s and the agency’s time and resources? One obvious reason is the real and potential tragedy involved. For example, government and industry have invested heavily in oncology research, resulting in cures for some cancers and turning other cancers into treatable chronic diseases. It IS a crisis when patients cannot receive those therapies because of shortages. Infant formula shortages are another example of the potential for tragedy.

Another reason for the priority and attention given to product shortages is the heterogeneity of responses needed. Each shortage has a root cause that needs a custom solution. Many shortages require the involvement of dozens and sometimes hundreds of different players and a substantial time and manpower investment by FDA. A third reason for the attention is that, not surprisingly, product shortages are felt at the grassroots level more personally than many other FDA issues.

The Alliance is concerned whether FDA has sufficient money and manpower to address shortage problems and other critical programs in its expanding mission and growing responsibilities.

Solving product shortages involves more than just resources. However, money and manpower are always key to FDA’s ability to address problems.

Editorial Note:
The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.