Industry Questions FDA Drug Shortage Reporting Timeline

The drug industry wants the FDA to drop plans to require drugmakers to report manufacturing stoppages that will result in shortages within five days of the stoppage occurring. If any timeline is imposed, 15 days is adequate, industry says.

The FDA last year announced the requirement as part of a proposed rule to counter shortages of life-sustaining drugs. The agency wants six months lead time when essential products are to be discontinued or experience an interruption in manufacturing.

But PhRMA and GPhA, in comments submitted on the rule, say there may be cases when the five-day deadline is too short to allow for an analysis to determine if the interruption will result in a supply disruption.

The groups say the FDA should stick to language included in the Food and Drug Administration Safety and Innovation Act (FDASIA) stating that drugmakers should be required to report drug shortages “as soon as practicable” versus setting a hard timeline.

“However, if FDA requires a specific time period for reporting, it should be no shorter than 15 business days, which is a more reasonable timeframe for manufacturers to investigate and confirm how the actions taken in response to the interruption will affect the ability of the manufacturer to fill orders or meet expected demand,” adds PhRMA.

The Biotechnology Industry Association (BIO) said it’s also not clear in the proposed rule when the timing clock begins for reporting. “For example, it is unclear as to whether the clock begins on the date of the event causing the interruption, or on the date the applicant becomes aware that an interruption could cause a shortage,” BIO said, adding that such timing should be clarified so that it can be enforced fairly.

PhRMA expressed concern with the agency’s intent to publically name companies that don’t comply with the rule, saying manufacturers should be allowed an opportunity to resolve such issues with the FDA before such actions occur.

Not everyone in the industry agrees. Amgen commented that it supported the provision, even going so far as to suggest the FDA notify major news services of noncompliance.

Amgen was concerned, however, with the agency’s intent to publish information on potential drug shortages. “This may lead to hoarding by distributors, pharmacies, hospitals and other purchasers and may cause or exacerbate a situation that otherwise could have been manageable,” the drugmaker said.

A key concern for PhRMA is whether the term “products” under the proposed rule could lead to unnecessary drugs ending up on the FDA’s drug shortages list. PhRMA notes the recently passed Drug Quality and Security Act allows compounders to produce comparable drugs once they are on that list.

“A broad definition of the term may allow drug compounders to begin manufacturing a specific drug before it is actually necessary, at the possible peril of public health,” PhRMA said.

Similarly, GPhA says the broad definition used by the agency encompasses “a majority of the current approved drugs and biologics” and recommends the agency work with industry to determine which products should properly be considered “life-supporting or life-sustaining.”

GPhA also says the FDA should borrow strategies from the EU, which would allow certain expired products to be used to temporarily manage drug shortages if they pass inspection, as well as the use of drugs from other markets if they meet certain standards.

Pfizer in its comments also stressed the need to refine the definitions. Pfizer said as proposed, the definitions could result in over-notification to the agency. The agency could be bombarded with notifications of brief supply interruptions that may not have a meaningful impact on patients, Pfizer said. The drugmaker recommends that within one year after implementing the rule, the FDA assess whether over-notification has occurred.

The deadline to comment on the proposed rule, docket no. FDA-2011-N-0898, closed on Jan. 3. 34 comments were submitted. The agency is working quickly to develop a final rule, but it will not meet the Jan. 9 deadline for the final rule mandated by FDASIA.

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