FDA has placed restrictions on certain drugs that are either dangerous or prone to abuse, in some cases only approving them for hospital use. The problem is that generics manufacturers need samples of the brand-name drug in order to carry out comparative clinical trials with the generic drug and so prove bioequivalence, but these restrictions block the flow of the drugs to wholesalers. This then means that generics manufacturers cannot buy samples of the brand-name drugs that they need in order to develop their generics.

Generics manufacturers are complaining that brand-name manufacturers are exploiting these FDA restrictions as a way to prevent generics competition, and according to The Washington Post, critics have warned that ‘the practice is bound to become more entrenched and widespread.’

The Federal Trade Commission has launched an investigation into the matter and the US Senate is also addressing the complaint in a provision included in a broader measure that funds FDA.

This is not the first time this issue has been brought to the attention of the US Government. Back in 2009 generics giant Dr Reddy’s Laboratories submitted a citizen’s petition to FDA accusing Celgene of using these restrictions as a means to block generics competition by refusing to sell samples of its blockbuster cancer drug Revlimid (lenalidomide). The drug, being a derivative of the notorious thalidomide, is known to cause serious birth defects when taken by pregnant women and is therefore distributed only to patients, doctors and pharmacies registered with Celgene. This, however, makes it impossible for a generics manufacturer to gain samples of the blockbuster drug needed in order to develop a generic version. Celgene, however, argues that they are under no obligation to sell their drug to a competitor.

The issue is still not resolved and it is perhaps about time that FDA addressed Dr Reddy’s request that brand-name manufacturers ‘sell, at fair market value, a sufficient quantity of their drug product to a proposed generics applicant for bioequivalence testing purposes’.

Editor’s comment
This is obviously a serious problem. If generics manufacturers cannot get hold of samples of the brand-name drug they cannot develop generics. This will then have the knock-on effect that patients and payers will not gain the massive savings that occur when brand-name drugs go off patent.

Please feel free to share your thoughts via email or in the comments section below. What are your views on this issue? Should generics manufacturers have the right to buy samples of brand-name products?

If you would like to receive a copy of the Dr Reddy’s citizen petition, please email us.

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