Drugs

Generics Seek Legislation to End Drug Sameness Delays

The Association for Accessible Medicines (AAM) is urging Congress to pass pending legislation to allow FDA to disclose “sameness” information about a brand drug to potential generic drug makers. Without these disclosures, brand drug makers are allowed to game the approval system to claim a product’s inactive ingredients are trade secrets, the generic trade group says in a blog post.

Called “Q1/Q2 sameness,” these inactive ingredient compositions, and brand company protections of them, have been behind numerous generic drug delays, particularly competition for critical complex products, according to AAM.

A proposed generic drug formulation can meet Q1/Q2 sameness requirements if the proposed product “contains the same inactive ingredients (Qualitatively the same, or Q1) in essentially the same concentration (Quantitively the same, or Q2),” AAM explains. “But if a generic drug fails to meet this FDA requirement, then the FDA can refuse the generic drug application out of the gate when it is submitted, or worse — refuse the drug years later when the FDA may be poised to make an approval decision, causing the generic drug manufacturer to either abandon the drug or go back to the formulation drawing board.”

AAM says legislation is needed to fix the brand name drug industry’s delay tactic. Specifically, the Increasing Transparency in Generic Drug Applications Act, which has passed legislative committees in Senate and House committees, “would authorize FDA to cut through the bureaucratic red tape and disclose to a generic manufacturer the ingredient or ingredients that cause a proposed generic drug formulation not to be Q1/Q2 the same as the brand-name reference product formulation and, if necessary, the amount required for an ingredient to be quantitively the same as the brand-name reference product,” AAM says. “Congress needs to act now to clarify and codify the FDA’s authority to disclose Q1/Q2 sameness information to generic drug manufacturers, and to avert a legal challenge to the FDA’s current regulations and process that could further slow generic drug access and availability.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome