The guidance is part of the broader FDA Drug Competition Action Plan that was introduced in June 2017 with the intent of increasing competition in the drug marketplace and facilitating entry into the market for lower-cost alternatives. In the coming months, FDA is expected to issue additional guidance.
Breaking Barriers
Gottlieb says the new guidance, issued October 12, will make it easier for generic drug manufacturers to enter the market, which should lead to more generic drug options for consumers.
“The increased transparency and predictability provided by these and other product-specific recommendations gives applicants seeking to develop generic copies of these complex products a better opportunity to efficiently advance these products and prepare better and more complete submissions,” Gottlieb said in a press statement.
“In too many cases, there is no generic competition for these costly branded drugs even after they have lost their exclusivity protections,” Gottlieb said. “We have made a new commitment to develop product specific guidance documents laying out how to develop a generic copy of a branded medicine for any currently marketed, branded complex medicine, in an effort to advance a more efficient and effective framework for developing generic copies of complex drugs. We will strive to release each document as soon as scientific recommendations can be developed.”
Streamlining the Approval Process
Generic drug development has increased under the Trump administration, with the FDA reporting record numbers of generics approved in 2017.
Edward Hudgins, research director for The Heartland Institute, which publishes Health Care News, says the quicker approval of generics and the focus on creation of generics for complex drugs will help lower drug prices and increase patients’ access to treatments.
“The FDA’s approval of so many generic drugs in the past few years indicates it has gotten the message from Administrator Scott Gottlieb and President Donald Trump that the needs of patients, rather than slow-moving bureaucrats, are a priority,” Hudgins said. “The increasing availability of generic drugs will certainly take pressure off some drug prices.”
Traditionally, TDS drugs are delivered via a skin patch, which makes them more difficult to develop as a generic because of the complexity of delivering drugs through the skin.
Incentivizing Investment
FDA is also increasing incentives for drugmakers to develop generic versions of drugs that currently lack competition through the Competitive Generic Therapy (CGT) designation, which accelerates the review process for generic drugs for which there are no generic alternatives. A drug can be designated a CGT if there is “inadequate generic competition for that drug, meaning there is not more than one approved drug,” according to an August FDA statement announcing a new pathway for approval of sole-source generics.
“This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need,” Gottlieb said in the statement.
Reforming Regulations
The creation of incentives for drug manufacturers to invest in research and development of generics (especially for complex drugs) is a step in the right direction, though more regulatory reforms are needed to make prescription drugs more available and affordable, Hudgins says.
“There are deeper problems with the government’s convoluted regulations of pricing, especially through Medicare and Medicaid, as well as the FDA’s certification process for new drugs, which contribute to the $2.6 billion and 10–12 years it takes to bring a new product from lab to patient,” Hudgins said. “To ensure that innovative medications reach customers at the most reasonable prices possible, more fundamental government reform is needed.”
Cory Compton (thecomptonjr@gmail. com) writes from Cheboygan, Michigan.
