Q&A: The state of generics with GPhA’s Chip Davis
As Congress continues to look into the question of drug prices with hearings in early February featuring industry experts, one of the organizations being turned to is the Generic Pharmaceutical Association, whose president and CEO Chip Davis recently responded to the Senate Health, Education, Labor and Pensions Committee about the state of the generic drug industry. Drug Store News spoke to Davis about the year ahead for GPhA and what some of the biggest battles for the generic drug industry will be.
DSN: You started the year calling for the passage of the FAST Generics Act — what are some of the biggest benefits the industry and patients will see if that bill makes it to the president’s desk and he signs it into law?
Chip Davis: Misuse of FDA REMS patient safety programs is one way that certain brand drug companies delay generic competition. Failure to address the loophole that makes these abuses possible is a missed opportunity to encourage more competition in generic drugs and to generate billions of dollars in additional savings for patients and the health system.
DSN: One of the items GPhA is wary of is compounding alternatives to certain drugs. What are some of the potential pitfalls of allowing compounding to take the place of approved generics and how do you hope to find a different solution?
Davis: Rising health costs are unsustainable for patients and our health system. However, encouraging mass compounding via “outsourcing facilities” or drugs that are unapproved by the FDA, such as the compounded alternative to Turing’s Daraprim, creates avoidable patient safety risk. Circumventing the FDA approval process is not the answer.
Generics are currently 88% of prescriptions delivered at less than a third of total U.S. drug costs. Competition from FDA-approved affordable generic alternatives remains the best way to drive down health costs. There are ways to boost access working through, not around, FDA safety and approval processes. The backlog of 3,800 generic applications pending approval must be addressed. Misuse of FDA REMS safety programs by some brand drug companies continues to impede generic access and must be stopped. GPhA will continue leading a constructive dialogue that prioritizes patient safety and savings to ensure generic competition can keep drug costs low.
DSN: Another safety issue GPhA raised recently concerns labeling and adjustments that manufacturers would have to make without FDA approval — what are the issues with this proposed change and what’s a way to avoid them?
Davis: GPhA is pleased that the Food and Drug Administration will continue to evaluate the wide range of concerns expressed over the currently proposed changes to generic drug labeling requirements. GPhA continues to support the Expedited Agency Review, a better way forward that strengthens the communication of drug safety information without putting patients at risk. Current law requires brands and generics to carry the same label to assure healthcare practitioners have consistent information to inform their decisions and patient conversations. The proposed rule would change this by requiring generic manufacturers to update labels based on incomplete information without first receiving FDA approval. However, no single manufacturer has access to the full range of available data — the proprietary data from clinical studies or the data held by each individual applicant holder.
The FDA is the only entity with all of the data needed to recommend a safety information change. Instead, the EAR suggests time parameters for the FDA to take action and encourages the adoption of e-labeling for real-time information sharing rather than continuing the reliance on paper label changes that take months or years to adopt. The EAR also takes important steps to make sure that multiple different labels do not exist for products with the same active ingredients, safety and efficacy. GPhA will continue to work with the agency and other stakeholders committed to advancing and protecting patient health to ensure that any changes to labeling regulations do not put patient safety at risk and avoid causing provider confusion.
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