Ingredients

FDA proposed rule could delay import of excipients, PhRMA says

15-Jul-2014
Last updated on 15-Jul-2014 at 09:53 GMT - By Zachary Brennan
The industry group also takes issue with the FDA’s estimates of how many drugs will be destroyed each year.
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Although industry group PhRMA has called for the full implementation of a proposed rule that would allow the US FDA to destroy detained drugs deemed to be counterfeit or unapproved, the group also warns that such destruction could lead to manufacturing delays.

The exercise of the new authority could inadvertently also entangle and delay the importation of low-value excipients and other drug components, however, which could in turn result in manufacturing delays in the US of important, life-saving medicines,” PhRMA said in its comments on the proposed rule.

Under the rule, the FDA would be allowed to destroy any drug valued at $2,500 or less that has been refused admission to the US. The owner or consignee of the drug would be notified of the pending destruction and would be allowed to provide testimony prior to the destruction.

PhRMA and its member companies urge extra caution for when the FDA uses this new destruction authority. FDA should use this authority “in close coordination with manufacturers to limit any impact on supply chain continuity,” PhRMA says. “To assist with ensuring that the agency’s use of this new destruction authority does not inadvertently lead to a disruption in the pharmaceutical supply chain, PhRMA recommends that the agency ask its Drug Shortages Task Force to specifically monitor and publicly report on the effects, if any, of the new destruction authority on the drug supply.”

More Data Needed

The industry group also takes issue with the FDA’s estimates of how many drugs will be destroyed each year. The FDA, according to its regulatory impact analysis, estimates 12,100 destructions will be performed each year, though “PhRMA believes that the number of parcels entering the US containing violative drugs valued at $2,500 or less could be far higher based on figures cited by FDA in the preamble to this proposed rule.”

In the preamble, FDA says that the US Postal Service estimates that over one year, the number of parcels containing drugs that come to the US via international mail is between 20-100m, of which FDA examined nearly 45,000, and from these shipments, the CBP (Customs and Border Patrol) seized over 14,000 illicit imports.

If this 30% seizure rate of illicit drugs is representative of all shipments, then it could be estimated that at least 6 million illicit shipments of drugs enter the U.S. each year,” PhRMA says, noting that by this standard, the 12,100 destructions per year would only address 0.2% of the violative drug importation problem. “Though PhRMA recognizes that these calculations may not be reflective of the actual number of illicit imports, they suggest that further research is needed.”

Further Clarification

PhRMA and its member companies also seek more clarity on situations in which the FDA will destroy a refused drug and in which situations FDA will export the refused product.

Shipping giant FedEx also seeks more information regarding “operational details and explanations” before the destruction policy is enacted. “The existing return policy for FDA shipments refused entry utilized by FedEx keeps costs low and insures charges are made to the shipper or recipient accounts. The removal of that option requires clarification to ensure that the carriers do not suffer unexpected negative economic impact,” FedEx says, in contrast to PhRMA, which seems encouraged by the prospect of destroying illicit drugs to prevent their re-entry into the US.

The industry group also recommends that the FDA consider establishing a database that ports can check to determine whether or not a shipper has been involved in multiple attempts to ship violative drugs into the US illicitly.

Pushback from Senators

While PhRMA and FedEx seem largely supportive of the rule to allow the destruction of certain illicit packages of medicines, a letter from Republican Sens. David Vitter (La.), Chuck Grassley (IA), Dean Heller (NV) and Independent Angus King (ME) expressed their disappointment over the rule, which may end up restricting the importation of drugs from pharmacies in Canada.

 “This proposed regulation constitutes a potential health threat to hundreds of thousands of Americans who receive their affordable drugs from safe, licensed and legal pharmacies in Canada,” the senators said.

The senators also request that the final regulation contain a requirement that patients be notified that their drugs could be destroyed at least six months in advance of their medication being denied to them. 

Related topics: Globalisation, Ingredients, Excipients, raw materials and intermediates, QA/QC, Regulations