Posted 23 May 2016
By Michael Mezher
The US Food and Drug Administration (FDA) is reminding pharmaceutical companies that they have until 10 June 2016 to submit information FDA needs to prepare invoices for the upcoming fiscal year.
The reminder, which comes in the form of a "Dear Colleague" letter sent to drugmakers earlier this month, instructs companies to complete two attachments to inform the agency of any of a company's products and establishments that are subject to user fees.
Under the Prescription Drug User Fee Amendments of 2012 (PDUFA V), FDA has the authority to collect fees from industry to help support the agency's workload. Specifically, FDA collects three types of user fees for new and supplemental applications, product-related fees and fees that cover manufacturing facilities.
The agency will issue the FY 2017 product and establishment invoices in August.
For "Attachment A", FDA asks that companies update their contact information for where information and invoices related to prescription drug user fees should be sent.
For "Attachment B", companies are told to add any new products or formulations that are subject to product fees, delete any products that are no longer subject to a fee and list the establishments where any new finished products are manufactured. For new products subject to fees, and products no longer subject to fees, FDA asks that companies provide their reasoning as to why the fees are, or are no longer, applicable.
For discontinued products, FDA says that companies have until 1 July to notify agency staff of a discontinuation to avoid being invoiced. If a company is invoiced for a product that is no longer marketed, FDA says the company may receive a refund as long as they notify the appropriate agency staff by 30 September 2016.
Under PDUFA, facilities that manufacture the "final dosage form" of a drug or biologic are also subject to an establishment fee.
In the letter, FDA asks that companies add the name and address of all sites (including sites owned by contract manufacturers) that manufacture any of the products in a numbered list. Additionally, FDA instructs companies to list any establishments they that are used to manufacture final dosage forms for other companies in a separate list.
FDA is currently negotiating with industry and other stakeholders on the next iteration of PDUFA, which will take effect in 2017.