FDA to Increase Generic Competition of Complex Drugs

Pharmacy TimesApril 2019 Mental Health
Volume 85
Issue 4

The agency released some of their efforts to improve patient access to generic medicine this year.

The FDA has recently increased efforts to promote drug competition in order to drive down costs and increase patient accessibility to necessary medications. In 2018, officials created policies that to make the process of generic approval and market entry more efficient.

Officials are zoning in on increasing access to a specific category of medicine—complex drugs. Due to complex formulation processes, delivery methods, or active ingredients are more difficult to genericize. As a result, the cost of complex drugs can be a huge burden on patients who need them.

Although many of the patents for these drugs are no longer in effect, a lack of competition still exists due to the difficulty of genericizing these products. The FDA plans to address this issue by continuing to enforce policies already in place and creating additional policies in 2019 to promote competition among complex drugs, according to a press release from the organization.

One reason why generic entry can be difficult for complex drugs is because generic drug policies have not kept up with advancements in medicine over the past few decades. When generic drug legislation first came to the forefront 1984, most brand medicines were simple molecules that had straightforward manufacturing processes, making them relatively easy to reproduce and evaluate. Most of the drug activity could be measured by how quickly it entered the bloodstream, and how long it stayed there, according to the press release.

Complex drugs, however, are much harder to reproduce and evaluate due to complex formulations or active ingredients. Some of these drugs are harder to evaluate as they act locally on the tissue, as opposed to in the blood. Examples of this include inhalers that act directly on the lungs, topical patches that are absorbed into the skin, or eye drops that act on the surface of the eye. The activity of these drugs is independent on the amount in the blood, making it hard to measure through blood, and therefore harder to meet the standards for generic approval, according to FDA officials.

The FDA plans to address this by issuing guidance documents for developing both specific complex drugs and categories of drugs that are hard to copy. This organization will also publish a series of guidances addressing regulatory and scientific challenges that increase the difficulty level of genericizing complex drugs. One key part of this will be a draft guidance with recommendations on creating sameness between active ingredients, according to the press release.

Additionally, officials intend to advance the development of both analytical tools and in vitro testing, that may lead to insight on accurate, sensitive, and reproducible tools. Improving the tools used in generic manufacturing of complex drugs can reduce the time and cost of drug development, leading to an overall smoother process, according to the FDA.

The FDA’s goal with these additional policies and guidances is to ensure scientific and regulatory transparency between the FDA and generic manufacturers for complex drug development. These efforts have become increasingly important, primarily because complex drugs provide important and necessary therapies to patients. Other factors in these efforts include driving economic growth within the generic drug industry, as genericizing complex drugs creates high value opportunities for generic drug companies, according to the FDA.

These are just some of the FDA’s plans to improve competition among complex drugs in 2019. Efforts by the FDA to foster generic market entry is key in the agency’s efforts to increase patient access and affordability.


  • Statement from FDA Commissioner Scott Gottlieb, MD, on 2019 Efforts to Advance the Development of Complex Generics to Improve Patient Access to Medicines. FDA Press Room. January 30, 2019. Link. Accessed February 18, 2019.

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