Legislator Asks for FDA Evaluation of Several Novel Ideas to Solve Drug Shortage Crisis

The issue of drug shortages may have largely fallen off the media's radar, but it hasn't stopped being a problem for consumers. Now, in a letter to the US Food and Drug Administration (FDA), Rep. C.W. Bill Young (R-FL) has called on Commissioner Margaret Hamburg to evaluate several new ideas that could act to mitigate or eliminate the shortage crisis.

Background

Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injectable drugs experiencing supply shortages. Investigations into the matter brought to light a number of reasons for the shortages, including:

• gray market pharmacies purchasing drugs experiencing low stock, and then re-selling 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 has taken a number of actions intended to mitigate the effects of drug shortages over the course of the last year. Among them:

• allowing the import of certain unapproved drugs to ease especially dire shortage situations
• asking manufacturers to notify FDA of any impending supply problems or disruptions
• working one-on-one with manufacturers experiencing problems
• approving 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).

But more remains to be done. Under the FDA Safety and Innovation Act (FDASIA), FDA is charged with formulating a strategic plan on drug shortages (Title X, Section 506D of FDASIA).

That strategic plan is to include ways to "improve interagency and intra-agency coordination, communication and decision making," and mandates that FDA consider the possibility of drug shortages when conducting any regulatory action against a manufacturer. The effects of drug shortages on clinical trials, the possibility of establishing a "qualified manufacturing partner program," and communication plans will also be considered.

Such a "qualified manufacturing partner program" would potentially allow a third-party manufacturer to produce drugs in short supply so long as they have the "capability and capacity" to supply those products. FDA is also set to examine whether incentives are necessary to allow qualified manufacturers to participate in the program.

The report is due "as soon as practicable."

Same Old Problem Prompts New Ideas

In the meantime-and despite FDA's reported progress in reducing the impact of them-drug shortages persist, something not lost on Young.

In a letter to Hamburg on 25 September 2013, Young said he remained concerned about the effects of shortages, which have tripled over the last five years. "I realize this is a very complex problem that cannot be solved overnight," he conceded, noting the various initiatives underway at FDA to look at the problem.

Young asked that FDA study five possible approaches to abating drug shortages:

• Could FDA link new drug patents with a commitment to new or continued production of generic or low-cost drugs deemed by FDA to be "critical?"
• Would FDA be willing to develop or require real-time monitoring for generic drug volume utilization versus manufacturing production volume to determine if adequate production levels are met?
• Could FDA incentivize production or arrange for importation of similar products if generic drugs begin to experience a shortage?
• Could FDA be required to remove regulatory barriers that impact the importation of "safe substitute products" and establish a national stockpile of drugs otherwise in short supply?
• What would the impact be if FDA stockpiled drugs known to experience chronic supply shortages? How much supply should be permitted?

Young said he is looking forward to a "prompt" reply from Hamburg.