The FDA and generic drug labeling changes

Every day millions of patients around the world rely on generic medications to help them to live active, pain-free, healthier and longer lives. In fact, 84 percent of the medicines dispensed in America today are generic drugs that saved the United States health care system more than $1.2 trillion during the last decade, enabling access to treatments that are all too often prohibitively expensive.  Generic medicines are accessible, affordable and reliable. That is why a new proposal from the Food and Drug Administration (FDA) is so troubling: it would undermine generic availability, and put both patient safety and health care savings at risk.  But, if those concerns are still up for debate, one thing is not.  The FDA proposed rule would add to their cost.

Disappointingly, the FDA’s new proposed rule creates a regulatory framework whereby multiple, different drug labels, including different warnings, would co-exist simultaneously in the marketplace for the same drug with the same active ingredient. This would cause substantial confusion for pharmacists, doctors, nurses, patients and others in the health care system, upending 30 years of law and regulation.

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Current law requiring uniform labels for brands and generics provides certainty and assures all healthcare practitioners that they can rely on consistent information to inform their decisions and patient conversations. Identical labels underscore a critical point — once generic medicines pass through extensive FDA review, they are proven scientifically equal to the brand medicine in terms of safety, efficacy and quality. Under the proposed rule, doctors would be forced to follow a website of proposed changes without having any idea which changes will actually be adopted by the FDA.  The FDA would be burdened with responsibility for reviewing, tracking and approving a proliferation of label changes. As drafted, the rule would decrease patient access, impede healthcare decisions and delivery, and make fewer generic drugs available.

At the heart of the issue is the proposal for generic drug makers to unilaterally change their labels prior to FDA approval of the label information and based on incomplete information.  Generic manufacturers do not readily have access to the clinical trial data and evidence of the brand manufacturer or current information and data from other generic manufacturers; only the FDA has access to all data and information, as that information is proprietary. Since the FDA is the only entity that has access to all the information and has the expertise to evaluate and address this information, it is the only body in a position to decide whether a labeling change is warranted.

The danger of negative effects for patients, including a reduction in adherence to their doctor’s prescribed regime, is very real.  The proposal will lead to a flood of unnecessary labeling changes, and the exaggeration of risk and inclusion of unsubstantiated warnings will cause provider confusion and discourage the use of beneficial treatments.

That is why 21 organizations across the healthcare supply chain, including those that represent more than 100,000 pharmacists and more than 40,000 pharmacies have joined us in calling for change to this Proposed Rule. No one understands better than pharmacists the potential harm this proposed rule could engender. They are the ‘on the ground’ trusted experts who dispense more than three billion generic medicines that Americans use every year. The FDA should listen carefully to their concerns.

In addition to the negative public health impact, the proposed rule also would hurt consumers’ budgets. In fact, projections from Matrix Global Advisors show that this rule would cost America $4 billion annually, raising government spending $1.5 billion, and boosting private payer costs by $2.5 billion each year. The sustainability of our health care system, indeed our national economy, depends on the continued access to safe, effective, more affordable generic medicines in a timely manner.

There is too much confusion in today’s health system, so why add more in the form of multiple, different labels for the same medicines? Generic manufacturers support the idea of improving and streamlining the system, and we are eager to work with the FDA and the current Administration, in a multi-stakeholder collaboration, to assist the FDA in strengthening the current labeling regulations. Inclusiveness has to be the operating principle. The FDA should hear from pharmacists, physicians, patient advocates, payers, and others in the pharmaceutical supply chain who could offer expertise, experience, and perspective.

We can do better. Patients and healthcare practitioners must continue to have access to consistent, transparent information in order to best inform treatment decisions.  Let’s support a transparent process for timely submission of safety information that avoids confusion, helps protect patient safety and promotes access for the millions of Americans who rely on affordable generic medicines.

Neas is president and CEO of the Generic Pharmaceutical Association (GPhA).