FDA Bill Could Get Hearing Next Week

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The House Energy and Commerce Committee will hold a hearing next week to review an updated draft bill that would overhaul the Food and Drug Administration, several aides familiar with the initiative said.

The updated draft, known as 21st Century Cures, is expected to be released ahead of the hearing and will incorporate feedback from stakeholders. The first draft of the FDA legislation was released in January. Energy and Commerce Committee Chairman Fred Upton (R-Mich.), who was in Michigan this week for a field hearing on the FDA bill, told the Kalamazoo Gazette that he hopes the legislation is on the House floor by June for a vote.

Some Democrats on the panel had backed the bill while it was being written in 2014, but none publicly supported the legislation released earlier this year. The changes made over the past few months could help bring Democrats back into the fold. Rep. Diana DeGette (D-Colo.), who was the original member to work with Upton on the legislation, attended the Michigan field hearing.

But exactly what has been changed in the bill from the initial draft is not yet clear.

One potential change that some powerful players would like to see would deal with how much time brand-name drug makers get before generic drugs can start producing cheaper versions of those prescriptions.

The American Association for Retired Persons and other health trade associations, like the National Coalition on Health Care and the American Heart Association, are hoping proposals extending the so-called “exclusivity period” for certain products are dropped from the bill.

They argue that extending the amount of time brand-name drugs have a monopoly on the market drives up costs for patients. Brand-name drugs are typically much more expensive than their generic counterparts.

“If medical advances that come about are unaffordable, that pretty much makes them meaningless,” said Kenneth Hertz, senior legislative representative at AARP, said in an interview.

“They would basically prolong monopoly rights, keeping higher-cost, brand-named drugs on the market longer before a generic lower-cost could be introduced,” Hertz said.

But groups like the Arthritis Foundation and the American Thoracic Society, say a certain exclusivity provision – targeted to “dormant therapies,” drugs that have “one or more unmet need” – gives incentives to drug makers to develop new treatments.

“We are concerned that over time, manufacturers may choose not to reinvestigate the drug because the patent has expired or will expire before the research is completed,” Sandie Preiss, vice president of advocacy and access at the Arthritis Foundation, told the House Energy and Commerce Committee in a Feb. 13 letter.

Vijay Das, healthcare policy expert at Public Citizen, said the way the “dormant therapies” provision is written means it could apply to a wide array of drugs.

“When you read the statute closely, it’s actually fairly broad in nature in how they determine the drugs that would get exclusivity extensions,” Das said in an interview.

In a letter to the House panel, the Generic Pharmaceutical Association echoed those concerns, adding that the legislative language could lead to “evergreening,” a practice in which drug companies make changes to an existing product so it can get additional years of market exclusivity.

“The expansive definition of dormant therapies would sweep in drugs that would have been developed even without the special incentives or that have only marginal improvements over currently marketed drugs,” the group said in the letter.

AARP also questioned supporters’ claims as to whether increasing the exclusivity period would really lead to more innovation.

“There is also no evidence that increasing market exclusivity would result in an increase in innovation,” Joyce A. Rogers, senior vice president of government affairs at AARP, wrote in a March 2 letter to the committee. “In fact, there are indications that current incentives may instead favor market potential and profit.”

Upton and DeGette started the 21st Century Cures initiative last year, with the goal of speeding up the FDA’s approval process for new treatments.

After working with stakeholders, the Obama administration and health care experts, Upton released a “draft discussion” in late January outlining the proposals. More than 100 groups from across the health care spectrum responded. Organizations that represent patients and generic drug makers have focused on the exclusivity provisions.


Correction and Update: This article inaccurately stated the American Heart Association’s position on extending exclusivity for “dormant” therapies. The association has not taken a position on that proposal. Additionally, the length of exclusivity periods for different medical products were updated in this article.

Morning Consult