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FDA requests feedback on its guidances for generic drug development

The US Food and Drug Administration (FDA) has released its latest guidelines for the development of generic drugs and has requested feedback and comments on its guidance. Recently, the FDA has taken steps to increase the number of generic drugs available in the US and is on track to make a record number of generic approvals in 2017. In the 2017 fiscal year to date, the regulatory body has made 633 abbreviated new drug application (ANDA) approvals, only 18 less than the preceding year. 

Last month, the FDA held a public forum ahead of planned reforms to generic regulations and approvals. In his opening remarks, Scott Gottlieb, MD, FDA Commissioner said: "In too many places people cannot afford the medicines they need." He explained the current system supports "market-based pricing for innovation" as a means of incentivizing research and development of essential medicines. However, this system also allows for "vigorous competition" once patent rights on medication expire, he added. 

Generally, patent rights for newly developed medication run for around 20 years, after which time other pharmaceutical firms can develop generic versions of the medication, which is often significantly cheaper. Under FDA regulations, there are strict guidelines for generic medication. Before they are approved for the US market, manufacturers are required to prove their generic drugs are substitutable for the reference listed drug (RLD). Among the generics approved this year are four generic versions of Strattera (atomoxetine), used to treat attention deficit/hyperactivity disorder, and generic versions of Vytorin (ezetimibe and simvastatin), used to lower high cholesterol and triglyceride levels.

Generic medication must be: 
    • Pharmaceutically equivalent to RLD. This means it has to have the same active ingredient, dosage form, strength, route of administration

    • Bioequivalent to the RLD, which means it has no significant difference in the rate or extent of absorption. 

    • Therapeutically equivalent, which means it should be substitutable for the RLD with "the expectation the generic product will have the same safety and efficacy as the RLD. 

To encourage further development of generic drugs and improve the availability of cheaper medication, the FDA identifies a specific methodology for the development of drugs and the evidence required to support ANDA approval. Around eight out of ten prescriptions filled in the US are generic medications, according to figures from FDA. Generics are either "authorized" generic drugs or "traditional" generic drugs. Authorized generics are approved brand name drugs marketed as generic products without the brand on the label. Traditional generics are copies of brand-name drugs made by a company other than the original developer.