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Baby Formula Shortage Reporting Added to Senate FDA Fee Plan (2)

June 13, 2022, 4:06 PMUpdated: June 13, 2022, 9:36 PM

Infant formula makers would need to notify the FDA within five business days of a supply chain disruption under the Senate’s latest user fee proposal that’s expected to go before a committee markup Tuesday.

A substitute amendment to the proposal (S. 4348), obtained by Bloomberg Law, contains several provisions to improve Food and Drug Administration oversight of infant formula after a recall at an Abbott facility propelled a nationwide shortage. The user fee package is considered must-pass legislation and reauthorizes the payments that the drug and device industries make to help fund the agency.

Lawmakers are working to get a finalized user fee package done before the current authorization expires Sept. 30. The Senate health committee is scheduled to mark up the bipartisan package on Tuesday after the House passed its own version on June 8.

The Senate package would require the Government Accountability Office to issue a report on the FDA’s Division of Executive Operations and how it prioritizes complaints and other correspondence it receives from outside the FDA. The agency has cited isolated failures within the FDA’s mailroom as part of the reason why leadership wasn’t immediately made aware of claims of potentially contaminated infant formula from Abbott’s plant.

The latest proposal would also require the FDA to develop regulations that would facilitate the importation from Canada of certain prescription drugs for personal use. That measure also wasn’t part of the version introduced last month by Sens. Patty Murray (D-Wash.) and Richard Burr (R-N.C.), chair and ranking member of the Senate Health, Education, Labor, and Pensions Committee.

Sen. Bernie Sanders (I-Vt.) told Bloomberg Law last week that that he was looking to offer an amendment to the FDA user fee bill allowing for the importation of prescription drugs.

The latest HELP committee bill also adds in other measures from the House package that weren’t included in the previous Senate version. The legislation seeks to bolster generic drug competition by allowing the FDA to approve a generic drug even if the brand-name version’s label changes during the review process.

The agency would be required to give regular updates to Congress on user fee negotiations, and to publish the minutes from meetings within 30 days. Lawmakers had railed against the FDA for its delay in posting meeting minutes from its negotiations on its user fee deal with the medical device industry, and for transmitting it to Congress nearly two months past the Jan. 15 deadline.

Accelerated Approval

Language to revamp the accelerated approval pathway remain in the Senate HELP package, though it doesn’t include additional provisions on fast-tracked drugs that some advocacy groups hoped to see added.

The current package would give the FDA the authority to remove from the market any drugs that obtained accelerated approval if they fail to show a clinical benefit. It also states that the FDA may require post-market studies to already be underway before approval is granted.

Reshma Ramachandran, a Yale School of Medicine physician and chair of the Doctors for America FDA Task Force, has pushed for lawmakers to add in a proposal that would make a drug’s accelerated approval status automatically expire one year after studies demonstrating clinical benefit are scheduled to be done, or five years after the FDA grants accelerated approval, unless the drug company has met its post-approval requirements.

“Unproven drugs should be automatically removed from the market in a timely manner,” Ramachandran said Monday. She added that the FDA should also “make clear on their labels for accelerated approval drugs that clinical benefit has yet to be confirmed, thus providing patients and their doctors a transparent assessment of these promising treatments.”

Mark E. Miller, executive vice president of health care at Arnold Ventures, said he wants Congress to set a timeline for completing post-market studies. But he said he’s concerned the accelerated approval language will only get watered down as it moves through Congress.

“Come next week I don’t see it getting stronger,” Miller said. “The highwater mark is here.”

Cancer Research, Trial Diversity

Measures aiming to boost pediatric cancer research and clinical trial diversity didn’t make it into the substitute amendment.

Language based on the Give Kids a Chance Act (H.R. 6972) isn’t in the Senate package. The bill, which was added to the House package during a May 18 markup, would authorize the FDA to require companies investigating a drug combination for an adult cancer to also launch a pediatric study plan if there are molecular similarities.

Sens. Marco Rubio (R-Fla.) and Michael Bennet (D-Colo.) introduced a Senate version of Give Kids a Chance in May. Rubio’s office had said they wanted to get the bill into the package before the health committee’s markup.

“Committee markup is just one step in the legislative process,” Rubio’s office said Monday in an email. “The HELP Committee is committed to working with Senator Rubio to include his bipartisan Give Kids a Chance Act into the bill once it reaches the Senate floor.”

Nancy Goodman, founder and executive director of nonprofit group Kids v Cancer who helped craft that bill, said she was “disappointed that Give Kids a Chance Act was not included in the managers amendment.” She said she hopes to continue working with Rubio and Bennet to get it added before a final user fee package is signed into law.

“Give Kids a Chance Act provides potentially significant therapeutic gains for children with cancer in exchange for modest financial burden for industry,” she said.

The Senate proposal also leaves out a provision in the House version that would require drug and device makers to submit diversity action plans for their clinical trials as soon as practicable.

The Pharmaceutical Research and Manufacturers of America has said requiring diverse participation may make efforts to expand minority outreach seem disingenuous and pull resources away from addressing systemic barriers to medical research access.

Ramachandran said she’s “dismayed that there is no language in the bill to ensure meaningful representation of patients in clinical trials,” arguing that voluntary efforts among industry to boost diversity have largely been unsuccessful at delivering results.

—With assistance from Alex Ruoff

(Updated with additional commentary in the 12th and 22nd paragraphs.)

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com