Generic Drug Industry Group Seeks FDA Regulation Changes

Posted 25 April 2017 By Zachary Brennan


The Association of Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, has recommended five major US Food and Drug Administration (FDA) regulation tweaks in a letter to the Department of Commerce.

In addition to citing a lack of clarity in the regulations governing the permitting processes of large life sciences projects, David Gaugh, SVP for sciences and regulatory affairs at AAM, called for five actions to reduce the regulatory burden:

1. Eliminate the proposed rule, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” which AAM says could increase generic drug costs by $4 billion annually (or 5.4% of generic retail prescription drug spending in 2012), of which government health programs could pay an additional $1.5 billion, and private health insurance, $2.5 billion.

2. Finalize “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products” or remove 21 CFR 201.100 (c)(1). According to FDA’s analysis, AAM says, the annual net savings for such an action range between $10 million and $82.2 million.

3. Withdraw FDA’s plan to require the submission of quality metrics data, and increase dialogue between industry and the agency before guidance is developed. AAM and the Biosimilars Council estimate the cost to industry of this proposal to be between $934 million and $1.77 billion.

4. Modify implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (Docket FDA-2015-D-4750), which AAM says will “impair patient access to affordable alternatives to these important brand name biologics contrary to Congressional intent.” AAM also requests that FDA amend its policy to facilitate a streamlined transition for both approved and pending applications. “In the insulin market alone, FDA’s proposed policy could result in $6.65 billion lost savings per year to the U.S. healthcare system,” AAM says.

5. Remove 21 CFR 314.101(b) to allow abbreviated new drug application sponsors to have the same rights as new drug application sponsors in terms of requesting to file an application over FDA’s protest.


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Categories: Generic drugs, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: generic drug policy, AAM and FDA regulations, label changes for generics

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