US FDA introduces accelerated generic drug reviews

By Wai Lang Chu

- Last updated on GMT

Related tags: Generic drugs, Food and drug administration

The Food and Drug Administration are set to introduce a series of
measures that will accelerate the review process for generic drugs,
placing a priority on therapies that would address a public health
emergency or nationwide shortage.

In addition, the generic drug application will be speeded up if it is the first for a generic version of a drug no longer protected by a patent or market exclusivity.

The news is positive for generic drug manufacturers such as Watson Pharmaceuticals, Novartis AG's Sandoz unit and Teva Pharmaceutical as the priority reviews would aim to cut short a long, complicated and laborious process.

The Generic Pharmaceutical Association (GPhA) also reacted positively to the news saying that consumers would have more timely access to safe, effective and affordable generic medicines.

"Ensuring that at least one generic medicine will be available to consumers when a brand's patent expires is good news for consumers,"​ said President and CEO Kathleen Jaeger.

"By making generics more accessible, FDA is saving consumers and our entire healthcare system millions of dollars."

Under the FDA's new First Generics Policy, the agency will review select generic drug applications in six months, rather than the median time of 16 months.

Previously, the FDA reviewed all generic drugs on a 'first come, first serve' basis.

Generics currently represent 56 per cent of the total prescriptions dispensed in the US, but only 13 per cent of all dollars spent on prescription drugs.

And according to the Congressional Budget Office, generic drugs save consumers an estimated $8-10bn (€6.3- 8bn) a year at retail pharmacies. Even more billions are saved when hospitals use generics.

The issue was further deepened by the FDA's recent suggestion that generic drugmakers pay fees to have their applications reviewed.

Critics argued that such funds, also paid by device makers, force the agency to act in the interests of companies rather than patients and could lead to hasty approvals.

At a recent speech before the GphA, FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb said that the fees reduced approval times for brand-name prescription drugs and medical device.

He added that the fees "enabled more collaborative opportunities"​ between FDA and companies.

Gottlieb also mentioned efforts the FDA has made to reduce approval times for generic medications and said the budget for the agency Office of Generic Drugs had doubled since 2001.

"Median review times for generic medications are yet to drop below 16 months and applications pending per month have gone up from around 400 in the first quarter of 2002 to about 800 in the first quarter of 2005,"​ he said.

Related topics: Regulatory & Safety

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