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FDA makes news by doubling down on generic drug affordability

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Recently, the FDA announced they would take important steps in order to make generic drugs more affordable. On Monday, the agency doubled down on their action plan, by releasing a statement from its commissioner.

The overall goal of Scott Gottlieb, commissioner of the Food and Drug Administration, is to improve consumer access to the medicines they need.

Over time, the FDA’s new process could help lower generic drug prices

FDA officials do not control drug prices, but their policies do affect the ability to have competition in the market, which is why the agency is focusing on efficiencies related to the approval process.

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To be clear, the FDA is not introducing any sort of regulation on drug prices, but are hoping to help drug manufacturers more quickly develop generic alternatives to complex drugs. The hope is that this will drive down drug costs.

High drug prices are seen as a public health concern to the FDA, which is why Gottlieb feels the need to address the situation.

Policies related to complex drugs, like metered dose inhalers and injectable drugs, are where the FDA’s new set of major policies will be put in place.

What does this mean for consumers?

Consumers may not see the benefits of this new process for quite some time. This new approach is really aimed at helping manufacturers gain FDA approval for generic versions of complex brand name drugs. Though this will lower prices over time, drug manufacturers will need to take advantage of the FDA’s new approach, in order to make these complex medications more affordable. More competition means lower prices and savings being passed along to the consumer.

“These medicines generally have at least one feature that makes them harder to “genericize” under our traditional approaches,” said Gottlieb. “As a consequence, these drugs can face less competition.”

How will this new approach lower drug prices?

Simply put, the FDA plans to make it easier for drug manufacturers to develop complex drugs, like the EpiPen. This will create more competition.

As you may remember, Mylan Pharmaceuticals (maker of EpiPen) came under fire in late 2016, because they had inflated the price of the life-saving drug from $100 to $608 over the span of 10 years. The issue here is that there is no generic version of a device, like the EpiPen, to administer epinephrine that could live up to the FDA’s standards. In order to keep cases like this from happening, the FDA will provide “as much scientific and regulatory clarity as possible.” This approach should, in theory, allow drug makers to develop complex generics quicker.

This situation is unique, because it isn’t really the active ingredients that make complex drugs complex. In this case, Gottlieb is referring to more of the device, not necessarily the active ingredient.

Allowing easier paths to development, when situations like these occur, is a goal for the FDA.

“We’re doing all of this without sacrificing the scientific rigor of the process one bit,” said Gottlieb. “A central aspect of our approach, and our efforts to spur innovation and generic competition, is focused on adopting more rigorous and sophisticated science, including sophisticated quantitative methods and computational modeling, in drug development, evaluation, and review.”

Complex generic drugs and how the FDA plans to make faster approval possible

It is important that drug manufacturers prove the generic version of the complex drug is bioequivalent to their branded counterparts. Bioequivalence basically means the generic drug, for all intents and purposes, is the same as the branded drug.

The challenges surrounding generics and bioequivalence are what the FDA feels is deterring drug manufacturers from developing generic versions of complex drugs.

A road map is basically being delivered by the FDA, to drug manufacturers, to help assist them in knowing exactly what they are looking for, when it comes to development. The hope is that this process will allow for more communication between the FDA and drug manufacturers.

Bottom Line

This isn’t necessarily going to fix drug prices right away. The FDA’s commissioner says, in the letter released Monday, that over the next year the agency will identify gaps and develop more tools to help move this process along. At the very least, processes are being put in place and the FDA has identified that drug prices need to be a main focus of the agency.