Jessica Karins

Falls Church

FDA Reporter at Inside Health Policy

FDA reporter at @InHealthPolicy. Send tips to [email protected]

Articles

Rare Disease Group Slams Cancellation Of Newborn Screening Ad Comm

20 hours ago | insidehealthpolicy.com | Jessica Karins

The abrupt termination of a Health Resources and Services Administration (HRSA) advisory committee raised concerns about the future role of advisory panels around HHS, coming as the department also signals it could make changes to committees’ membership.
Second Potential mRNA Vaccine For Avian Flu In Development

20 hours ago | insidehealthpolicy.com | Jessica Karins

United Kingdom-based DIOSynVax and Singapore-based ACM Biolabs are collaborating on development of a next-generation avian influenza vaccine that could combat a potential pandemic, the companies announced Tuesday (April 22).
Novavax Says FDA Has Requested Post-Market Study On COVID Vaccine

1 day ago | insidehealthpolicy.com | Jessica Karins

Novavax announced FDA is seeking additional postmarketing commitments on its protein-based COVID-19 vaccine, after high-level FDA officials took the unusual step of delaying the full approval of the shot, which has been broadly administered under emergency use authorization since 2022.
Major Pharma, Tobacco Critic Dick Durbin To Retire From Congress

1 day ago | insidehealthpolicy.com | Jessica Karins

Senate Democratic Whip Dick Durbin (D-IL), a longtime advocate for reducing drug prices and the author of the 2009 law giving FDA authority to regulate tobacco, has announced he will not seek reelection for another term in 2026.
FDA Will Ban Two Rarely Used Food Dyes, Work With Industry On Others

2 days ago | insidehealthpolicy.com | Jessica Karins

HHS’ actions to begin removing synthetic food dyes will begin with revoking the authorizations of two rarely used dyes, while the department says it will work with the food industry on phasing out the more commonly used food dyes and move toward authorizing natural alternatives. After teasing the pending policy change , Monday (April 21), FDA said Tuesday (April 22) its plans include setting a national timeline for the food industry to transition from synthetic dyes to natural alternatives. Its...
Harvard University Tells Court: NIH Grant Cuts ‘Slam The Breaks’ On Disease Cures

2 days ago | insidehealthpolicy.com | Jessica Karins

Harvard University is the latest plaintiff to file a case against the Trump administration over its disruptions of federal funding, telling a federal court late Monday (April 21) the administration is “slamming the breaks” on cures for diseases by withholding over $2.2 billion in funding that has nothing to do with Harvard’s disputed diversity and civil-rights policies.
Kennedy & Makary To Announce Ban On Synthetic Food Dyes

3 days ago | insidehealthpolicy.com | Jessica Karins |Maaisha Osman

HHS is set to announce Tuesday (April 22) an FDA effort to ban use of petroleum-based synthetic food dyes, the agency said, a major shift on food policy from the Trump administration that’s likely to meet with opposition from industry. HHS did not share details of the policy change but said HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary will announce it Tuesday at HHS’ headquarters, and added the plan will mark “a major step forward in...
FDA Guidances Advance To OMB Amid Plans To Deregulate

3 days ago | insidehealthpolicy.com | Jessica Karins

Two FDA proposed guidance documents on reducing the risks of cell and tissue products have been sent to the White House budget office for review, the first FDA regulatory documents to advance to the Office of Management and Budget since the Trump administration began its regulatory freeze. It’s a possible sign the administration could be returning to more normal procedures for FDA guidance documents, as the submissions came a day before agencies’ deadline to submit plans to reduce the number...
NCPA: Supreme Court Case Could Impact Lawsuits Against PBMs

3 days ago | insidehealthpolicy.com | Jessica Karins

A Supreme Court case brought by diagnostic testing company Labcorp could impact patients’ ability to file class action lawsuits across the health care industry, according to the National Community Pharmacists’ Association (NCPA), which argued in an amicus brief the case could also harm small businesses’ ability to sue pharmacy benefit managers. At issue in the case Labcorp v.
House E&C Plans Post-Recess Budget Markup; SCOTUS Appears Sympathetic To ACA Preventative Care Mandate

4 days ago | insidehealthpolicy.com | Dorothy Mills-Gregg |Jessica Karins

The Supreme Court led health care news this week with most of the justices appearing sympathetic to the Trump administration’s defense in oral arguments Monday (April 21) of the Affordable Care Act’s preventative care mandate, and while Congress is out this week, recent reporting shows the House Energy & Commerce Committee plans to meet in early May to mark up its part of the budget reconciliation package -- all as lawmakers unveil a couple bills over break, including one that...