The “times are changing,” but has the FDA remained in the past? Aduhelm, the failed Bioigen drug, should never have been approved, and the FDA’s guidance on DTC needs to be revised. The FDA needs new leadership and a visionary to lead the agency.
The FDA calls drug approval a “balancing act” between acceptable risks and benefits on its website. The FDA’s approval process may favor drug companies over consumers, and FDA approval does not guarantee safety. Big Pharma pays for the majority of drug safety reviews, provides the FDA with safety data for the review and has the option to have drugs approved faster with fewer clinical trials.
- Consumers don’t real pay attention to fair balance in TV ads.
- Pharma TV ads drive people online to search for more information.
- Safety pages on Pharma product websites continue to have high utility.
- Only requirement in TV ads should be for “boxed” products.
- Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. Source: Fierce Pharma
- If that enthusiasm pans out in the long run, it could mean at least 300,000 patients taking the drug, or $10 billion to $15 billion in peak Aduhelm from U.S. sales alone, which is above consensus estimates of around $7 billion to $8 billion, the team said.
- One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. history.” Source: STAT News
- Our healthcare system can’t continue to support drugs that don’t have good clinical outcomes behind them.
- Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product.
- The FDA’s recent approval of aducanumab (Aduhelm) shows just how badly the agency has failed the public.
- In late April, the FDA’s Oncologic Drugs Advisory Committee reviewed six accelerated approvals — a provisional pathway — involving a group of cancer immunotherapies where clinical trials had failed to confirm that the drugs extended survival or improved quality of life. Yet, in four of the six cases, the advisory committee voted to keep the accelerated approvals intact. (source: Medpage)
- In response to the FDA’s approval, three members of the Peripheral and Central Nervous System Drugs Advisory Committee who opposed approval of the drug quit the panel in protest.
- Physicians are signaling that they now want to see the “complete date” regarding new drug approvals.
IN SUMMARY: Under no circumstances can or should the US drug approval process come under questioning by the press or patients. This administration has shelved science and replaced it with politics and pseudoscience which endangers us all.
QUICK READ: The Federal Drug Administration’s Office of Prescription Drug Promotion (OPDP) on Wednesday issued the first warning letter specific to paid-search ads since 2014. The FDA said that the search results did not include any fair balance. This is an example of how out of date the FDA’s Office of Prescription Drug Promotion (OPDP) really is.