Generics Group Opposes Changes to 180-day Exclusivity
The Association for Accessible Medications (AAM) is stepping up pressure on Congress to reject legislation to change FDA’s 180-day marketing exclusivity award for “first generics” that are the first to challenge brand-drug patents. The bill, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act (HR 938), is intended to prevent the first generic product makers of a class of drugs from “parking” their exclusivity awards and thus blocking subsequent generic approvals (see earlier story).
AAM says that the bill undermines the only incentive provided to generic manufacturers to challenge the patent thickets created by brand-name drug companies.” The group says that in recent years, generic and biosimilar manufacturers have found it increasingly difficult to bring more affordable medicines to market due to rampant patent abuse. “Of the roughly 100 best-selling brand-name drugs, more than 70% obtained a patent to extend their monopoly beyond the initial 20 years,” the association says. “Challenging weak or questionable patents is an expensive endeavor without any guarantee of success... In 2017 alone, the top-12 grossing brand-name drugs were granted 71 patents on average for each drug. This level of patent protection delays competition by up to 38 years — well past Congressional intent.”
A new blog post by AAM Federal Government Affairs vice president Erik Komendant notes that a recent study found the BLOCKING Act would result in increased spending on brand-name drugs by an average of $1.7 billion for each generic delayed. “At a time of record FDA approvals of generic drugs, The BLOCKING Act would undo the progress made in recent years to increase patient access to first generics,” he said.
Since 2015, FDA has approved more than 450 first generics and these medicines comprise about 10% of all generics approved each year, Komendant says. First generics lower the price consumers pay for a drug by an average of 39%, he says, adding that prices fall even further as more generics enter the market.
“Bringing a first generic to market, however, is not easy or inexpensive,” Komendant says. “Congress recognized the risks and costs required to develop a first generic by making the first-to-file generic manufacturer eligible for a 180-day exclusivity period. This 180-day incentive is critical in the decision-making process of generic manufacturers when determining which medicines to bring to market and without it patient access to first generics would be delayed.”
Komendant says that increasing first generics is a proven, market-based solution that relies on competitive forces to lower drug prices. “Congress should preserve the 180-day incentive and its 35-year track record of success and not weaken it as the BLOCKING Act proposes to do,” he adds.