- In its pursuit to bring sky-high drug costs back down to Earth, the Food and Drug Administration has made one of its key goals under the leadership of Scott Gottlieb to bring more generic competition to market. On Monday, the agency continued that effort, issuing draft guidance specifically aimed at copycats of complex therapies.
- The two new guidance documents pertain to abbreviated New Drug Applications (ANDAs), which pharma companies use to gain approval for their copycat versions of branded treatments. In the one, the FDA detailed what complex generics manufacturers would need to make pre-submission and mid-review cycle meetings the most successful. In the other, the agency outlined when it's appropriate to file approval applications for generic peptide products.
- "Because brand-name versions of complex drug products are often higher-priced than many other brand name drugs, any steps we can take to encourage the development of generic competitors to complex drugs will have an outsized impact on access, and prices," Gottlieb wrote in a Oct. 2 blog post announcing the developments.
For an industry built on bringing innovative, life-changing therapies to patients in need, pharma doesn't exactly have a stellar reputation. One of the main reasons for that, at least as of late, has been the big price tags attached to new treatments.
Specialty drugs, for instance, are a growing class of expensive, hard-to-manufacture therapies that market analyzers predict will inflate healthcare spend in the coming years. At their best, these medicines are first-of-their-kind, offering treatment options to patients who otherwise wouldn't have any. At their worse, however, they underscore how high prices can prevent patients from accessing vital therapies.
The FDA knows well the strain expensive drugs put on both patients and the broader healthcare system. Since June, the agency has trying to increase competition — and, in turn, spurring prices to come down — by clearing the arduous path that generic drugmakers must take before they can market their copycat drugs.
Gottlieb wrote in his blog post that the agency will be working over the next year to figure out how to make the regulatory pathway for complex generics more efficient. As its name suggests, a complex generic mirrors a branded product that is difficult to produce, either because of its active ingredient, its administration or because it comes accompanied with a medical device. In the meantime, the industry will have time to consider and respond to the new draft guidance.
The guidance almost entirely relates to ANDAs. In general, the agency is attempting make the pre-ANDA program more robust and the meetings, both before filing and during the review process, more meaningful for drugmakers.
"We’ve found from analyzing our new drug program, that early and better meetings between FDA and sponsors can improve development timelines. We want to bring these same types of opportunities to developers of complex generics," Gottlieb wrote.
What's more, the FDA is focusing in on a specific kind of complex product: highly purified synthetic peptides. These peptides are made of 40 or fewer amino acids, and are found in products such as Eli Lilly & Co.'s Forteo (teriparatide) and Novo Nordisk A/S' Victoza (liraglutide). They also have been particularly difficult for generic drugmakers to copy.
"In this case, advances in technology for peptide synthesis and characterization allow an ANDA applicant for one of these products to demonstrate that its product meets the 'sameness' requirements for generic drug approval. The recommendations in the new guidance will help ensure that the risk of an immune response from the generic due to differences in impurities will not differ from that of the reference drug," Gottlieb wrote.
The FDA already updated the ANDA process earlier this year, revising the guidelines for what kinds of drugs are eligible for priority review status. With these latest initiatives, it's clear the agency doesn't plan on slowing down the reformation.
"We’re just getting started," Gottlieb wrote.