US News - A Threat to Affordable Medicine

Op-Ed

By Marsha Blackburn

Generic drugs saved Americans $1.2 trillion in pharmaceutical costs over the past 10 years, and $217 billion in 2012 alone. 84 percent of all prescriptions in the U.S. are filled with generic drugs. The success is due in large part because they have the same strength, dosage and active ingredients found in their brand counterparts, and yet they are more affordable.

The generic drug industry has successfully reduced the cost of health care for the past three decades, and yet at the request of the Obama Administration, the Food and Drug Administration has proposed to intervene and allow generic drug labels to differ from their brand counterparts. Disregarding the law in this way will create unwarranted confusion, raise patient safety concerns and threaten the system that has created thousands of affordable options for consumers.

The FDA has proposed allowing multiple therapeutically equivalent products with different safety-related labels to be on the market, which will naturally cause confusion among health care providers and patients.

The rule has other consequences as well that the FDA apparently did not consider. Only the FDA has access to all the data that the competing manufacturers compile about drug safety. Generic drug manufacturers do not have the luxury of research and development data, or post market surveillance from the time that brand products were under patent, and yet they would be liable under this new system for failing to warn about a side effect. The change could cause an explosion of litigation and higher insurance premiums, which in turn may force some generic manufacturers to exit the market or decline to enter the market, causing decreased supply and increased prices.

The key to the success of the generic drug industry is the requirement for "sameness" between generic drugs and the brand name counterpart in all respects, including the label. The FDA's proposed rule disregards specific portions of the Hatch-Waxman Law, which requires sameness in labeling and will allow generic drug companies to unilaterally change their labeling information. This action would put patient safety at risk, hinder access to affordable medicines and drive up health care costs.

A number of processes already exist whereby generic drug manufacturers can share new safety information and propose a label change. If the FDA believes that changes to those processes need to happen, they cannot simply ignore the law.

Congress has the unique authority to change laws and should be consulted if the FDA believes there is a need to do so. That is why I wrote to the FDA, questioning its authority in this matter as well as questioning the common sense of this rule.

I look forward to the answers that FDA will provide to the American people.

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