safebiologics.org

We're a non-profit org of patients, physicians, & biotech cos. working to ensure patient safety = the forefront of #biosimilars policy. #healthcare #biologics

[safebiologics.org @SAFEbiologics]

If Congress codifies #MFN drug pricing by importing foreign government price controls, Americans shouldn't be surprised if we also import those countries' reduced access to new medicines, treatment delays, and poorer outcomes. MFN=#MedicinesForNoone. @AndrewRSpiegel and Marcia Horn explain. https://t.co/FWMDVfoPJB @LADAOrg @GlobalCRC @CSROAdvocacy @WarOnCancer

[safebiologics.org @SAFEbiologics]

Read ASBM's Statement on the Senate HELP Committee's passage of S. 1954; opposed by 88% of US physicians. It would newly permit insurers and pharmacists to switch stable patients between biologics without FDA evaluation of safety and efficacy impacts or physician involvement. https://t.co/uVUOM10X8B @LADAOrg
@GlobalCRC @CSROAdvocacy @WarOnCancer @RogerMarshallMD @SenBillCassidy @GOPHELP @SenJonHusted

[safebiologics.org @SAFEbiologics]

88% of U.S. physicians oppose treating biosimilars like generics. Yet the Senate @HELPCommittee may do just that -handing insurers and PBMs unprecedented power to switch stable patients without physician involvement and potentially undermining treatment stability for millions. Former FDA Commissioner @PeterPitts explains. @LADAOrg @GlobalCRC @CSROAdvocacy @WarOnCancer @RogerMarshallMD @SenBillCassidy @GOPHELP https://t.co/3Za42P3aLF

[Global Colon Cancer Association @GlobalCRC]

Our CEO @AndrewRSpiegel has a new op-ed in @dcexaminer: The "Most Favored Nation" drug pricing policy could slow cancer cures and hurt the patients who need innovation most. There's a better path forward. 👇

https://t.co/4PPEfFmkQk

#CancerResearch #DrugPricing #PatientAdvocacy

[The Hill Events @TheHillEvents]

Live: A bipartisan conversation on the #MINIAct, legislation aimed at maintaining investments in cardiovascular innovation. @DonDavisNC (D-NC) and Rep. @claudiatenney (R-NY) join @TheHill's Kathleen Koch to discuss the path forward. #TheHillHealth https://t.co/cJeI9P3X3X

[safebiologics.org @SAFEbiologics]

ASBM is at the #TheHillHealth forum where @RepTenney and @RepDonDavis discussing bipartisan MINI Act, a technical fix to the IRA which now discriminates against genetically targeted therapies (GTTs). Mfg are disincentivized to invest R&D in these breakthrough therapies for heart disease, rare disease, other conditions. @GlobalCRC @LADAOrg @WarOnCancer

[safebiologics.org @SAFEbiologics]

"If a healthy America is the goal, then patients and manufacturers deserve a steady hand that builds trust and innovation, not continued chaos and confusion." ASBM's Cristina Beato MD, former HHS Asst. Secretary, writes of the chaos under @DrMakaryFDA's leadership. https://t.co/fWmYuGpW89 @WarOnCancer @GlobalCRC @LADAOrg @IFAiArthritis

[safebiologics.org @SAFEbiologics]

Erratic FDA Leadership is Creating a Crisis of Confidence, writes ASBM Executive Director Michael Reilly, reflecting on recent decisions by @DrMakaryFDA
@LADAOrg @GlobalCRC @WarOnCancer @IFAiArthritis
https://t.co/Qlg9RDqoxs

[safebiologics.org @SAFEbiologics]

Unregulated copycat versions of GLP-1s are a dangerous blind spot: Jimmie Wilson's GLP-1 prescription was filled by a local compounding pharmacy. Within weeks, he was suffering from acute liver failure and his only chance of survival was a liver transplant. Read the full story: https://t.co/k8RYyJvIeF

@GlobalCRC @LADAOrg @WarOnCancer @US_FDA @MartyMakary

[safebiologics.org @SAFEbiologics]

ASBM commends @SenatorBanks for introducing the SAFE Drugs Act — vital legislation to strengthen oversight of large-scale drug #compounding and protect patients from unsafe copycat medicines.

Read our full statement: https://t.co/nUOkjiHtCO @LADAOrg @GlobalCRC @WarOnCancer

[safebiologics.org @SAFEbiologics]

ASBM welcomes @DrMakaryFDA's reminder that FDA cannot verify the safety or quality of compounded drugs. We urge @US_FDA to back these words with strong enforcement so large-scale compounders can’t evade oversight or put patients at risk. Read our statement here: https://t.co/56r11F3fuk @GlobalCRC @LADAOrg @WarOnCancer @maxonwifi

[safebiologics.org @SAFEbiologics]

The world's regulators have long agreed: #Biosimilars are safe and effective - But they are NOT generics. In a new GaBI Journal editorial, ASBM authors warn FDA’s abrupt move to “genericize” biosimilars challenges decades of settled science and global regulatory policy - and potentially jeopardizes hard-won physician confidence, patient treatment stability, and savings.
🔗 https://t.co/hMdU0U1YPp @GlobalCRC @AndrewRSpiegel @IFAiArthritis @WarOnCancer @LADAOrg @patientaccess

[safebiologics.org @SAFEbiologics]

"Reforming #340B: Ensuring the Discount Program Delivers for Patients"- View the replay of ASBM's recent webinar with @GlobalCRC featuring health policy, medical, and patient experts including our own @MattieRheumMD & @AndrewRSpiegel. https://t.co/bp56SkiE8z @LADAOrg @WarOnCancer @patientaccess @IFAiArthritis

[safebiologics.org @SAFEbiologics]

Now starting: ASBM and @GlobalCRC webinar on 340B. Featuring experts from health policy, government, medicine, and patient advocacy! Join here: https://t.co/t6kIJyEW5H
@AndrewRSpiegel
@LADAOrg
@waroncancer
@IFAiArthritis
@patientaccess

[safebiologics.org @SAFEbiologics]

Is the #340B Program still serving the vulnerable patients it was designed to help? If not, what reforms are needed? Join ASBM & @GlobalCRC Friday Dec 12 @ 11am ET for a panel of health policy experts breaking down 340B’s challenges, transparency issues, and bipartisan reform ideas. Register now: https://t.co/z0yqyaiSZ2 @AndrewRSpiegel @LADAOrg @waroncancer @IFAiArthritis @patientaccess

[safebiologics.org @SAFEbiologics]

Axios reports most recent @FDA actions have been criticized as “deviating from established regulatory or scientific processes,” risking “undermining public trust.”
Insiders say FDA is relying on “the least amount of process” & “making things up as it goes along.”
Like suddenly eliminating clinical evidence requirements for and "genericizing" #biosimilars?@LADAOrg @GlobalCRC @GaBIOnline_ @patientaccess @IFAiArthritis https://t.co/9nQ4SgyrvE

[safebiologics.org @SAFEbiologics]

@GlobalCRC's @AndrewRSpiegel discusses how importing European-style price controls via the "most favored nation" #MFN drug pricing means European-style health outcomes: fewer new drugs, reduced access, higher death rates: #MedicinesForNoone @LADAOrg @WarOnCancer @IFAiArthritis @patientaccess
https://t.co/ggZcorj0Jv