Generics take the spotlight as House talks drug legislation

SUSANNAH LUTHI  March 13, 2019

House lawmakers and representatives for generic drug companies clashed Wednesday over how to handle exclusivity periods in a way that will bring more generics to market.

Witnesses before the House Energy and Commerce Committee's health panel warned lawmakers that a proposal to potentially override existing settlements between brand and generic drug manufacturers could disrupt business, and spur lawsuits that could ultimately go against Congress' goal of bringing more generics to market.

Rep. Nanette Diaz Barragán (D-Calif.) introduced the "Fair Act," which would allow a second generic company to share a 180-day exclusivity period for bringing the cheaper copy to market if the first generic manufacturer has entered a "pay-for-delay" agreement with the brand manufacturer. This bill would only apply to generic companies that have won a patent challenge in court or haven't been sued for a patent infringement by the competing branded drug company.

"Adding [that] would slow things down and lead to further litigation," Kurt Karst, director of the firm Hyman, Phelps and McNamara, told lawmakers.

Some Republican members of the committee latched onto these criticisms.

Rep. Fred Upton (R-Mich.) said he was "particularly concerned" that existing settlements between different companies would be affected, and Rep. Morgan Griffith (R-Va.) pressed witnesses point-blank about whether the bills could make generic entry more complicated.

Another bill, known as the "Blocking Act" also faced criticism Wednesday. The bipartisan measure by Reps. Kurt Schrader (D-Ore.) and Buddy Carter (R-Ga.) would let the Food and Drug Administration green-light a generic company's application to bring a competing drug to market if the first generic company to apply hasn't yet launched its product.

The bill has the Trump administration's support, and the White House called for the policy in its proposed budget earlier this week.

The House Energy and Commerce Committee's health panel was the first in both chambers of Congress to discuss legislation on drug pricing.

Chip Davis, the CEO of the chief generics trade organization Association for Accessible Medicines (AAM) and a witness during Wednesday's hearing, opposed both the Fair Act and the Blocking Act.

Michael Carrier, a professor with Rutgers Law School, said the legislation could prove to be "the most effective deterrent" to the type of settlements between generic and brand companies that stymie generic competition.

The clash over how to manage exclusivity protections for early generic competition was significant since both Congress and the Trump administration view the generics market as key to lowering overall drug prices.

The Energy and Commerce Committee, which has moved legislation at a clip this Congress, was the first in either the House or Senate to hold a hearing on specific bills for the upcoming package to address drug prices. The seven bills discussed on Wednesday are considered low-hanging fruit and included the popular bipartisan Creates Act meant to ease generics to market and longstanding "pay-for-delay" legislation.

Additionally, the subcommittee brought up two bills to make sure manufacturers maintain up-to-date with complete patent information in FDA Orange Book and Purple Book directories.

One bill, by Rep. Robin Kelly (D-Ill.), would require manufacturers to publish all patents related to a particular medication in the FDA's Orange Book directory. This could be significant for drugs whose high costs relate in part to patents for the devices used for application — such as insulin pens or other injectors or inhalers.

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