Sequestration puts speed bumps in drug review fast lane

Drugmakers paid a toll to build the FDA fast lane for drug approval, only to find it full of speed bumps created by the sequestration law that went into effect today. The agency is open and operating but now that it must cut about 9% of its budget for the remainder of the year, functions that were to be faster will now be, well, slower.

"All of that will add up to slowing the market entry of cost-saving generics," Claire Sheahan, vice president of communications for the Generic Pharmaceutical Association told The Philadelphia Inquirer.

The Office of Management and Budget has said that the cuts to the FDA budget will be about $210 million in the rest of this fiscal year. It also has said that the law applies to the user fees that drugmakers pitch in, something the Obama administration is pushing back on. BioCentury reports the White House has asked Congress to lift the sequestration lid on about $41 million in prescription drug and biosimilar user fees collected under the new PDUFA V program. If Congress obliges, the FDA could tap about $36 million for the rest of the fiscal year. 

It is not just drug reviews being held hostage by the across-the-board cuts. The agency is using some of its extra fees to expand inspections of API and finished drug manufacturing plants. That would have moved it further into areas like China where quality issues in the past have led to unsafe drugs getting into the United States.

The agency says that so far it does not expect to be putting employees on furlough, but it is still limited in what it can move forward on. It has been trying to make its case, as have other agencies, that consumers--in other words, voters--are not going to be happy with what this will mean to them.

"A sequestration of the magnitude contemplated, and this late in the budget year, will have public health consequences for an agency that is already making every dollar count," FDA spokeswoman Erica Jefferson told The Philadelphia Inquirer.

- here's the BioCentury story
- get more from the Philadelphia Inquirer
- and here is a Q&A from Alliance for a Stronger FDA

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