Researchers See Compounding, Imports as Fix for Pricey Off-Patent Drugs

Regulatory NewsRegulatory News
| 05 January 2016 | By Michael Mezher 

Three Johns Hopkins researchers are calling on the US Food and Drug Administration (FDA) to take action on expensive off-patent drugs by permitting bulk compounding and importation of generic formulations of the drug that are approved in other countries.

Typically, when a drug goes off-patent and generic versions become available, the price of the drug goes down significantly. Sometimes, due to limited demand or low returns, the market for a particular generic becomes uncompetitive and the number of manufacturers making those generics may drop to just one or two.

Recently, some companies, notably Turing Pharmaceuticals and Valeant Pharmaceuticals have taken advantage of this situation by purchasing the rights to off-patent drugs such as Daraprim and Isuprel and dramatically raising their prices.

While drugs such as Daraprim and Isuprel are long off-patent and open to generic competition, it could take years for another generic manufacturer to get approval for their own version through FDA's abbreviated new drug application (ANDA) pathway.

The authors of Role of the FDA in Affordability of Off-Patent Pharmaceuticals, published Monday in the Journal of the American Medical Association, propose three potential ways to address this issue.

First, the authors suggest that FDA could apply existing policy that allows the agency to expedite the review of generic drugs that could improve or prevent drug shortages to generics that "can have a major effect on competition and affordability in the market." Doing so, however, would likely be outside the FDA's purview as it would rely on the agency making economic considerations as factor in a drug's availability.

Second, the authors call on FDAto permit bulk compounding of specific drug substances, as described under the 2013 Compounding Quality Act. The authors caution that this is not an "optimal solution" as compounded drugs "are not tested for bioequivalence, they feel this approach could be used in specific circumstances where temporary access would trump the risks presented by compounding.

Third, the authors say FDA should "temporarily permit the importation of drug products reviewed by competent authorities and approved for sale outside the United States." The authors point to a 2012 case where FDA temporarily allowed the importation of an unapproved generic version of the cancer drug Doxil in order to ease a critical shortage.



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