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The U.S. health department's inspector general will review how the Food and Drug Administration grants accelerated approvals of new drugs, announcing a broad investigation,,,after two months of scientific controversy over the agency's June decision to clear Biogen's Alzheimer's drug Aduhelm...The FDA's own leader had called for a federal review last month in response to reports detailing unusual aspects of the close collaboration between the agency and Biogen in assessing clinical trial evidence for the medicine...READ MORE

GoodRx has entered into an agreement with Surescripts, to deliver drug discount price information to prescribers using Surescripts Real-Time Prescription Benefit when prescribing medications for uninsured patients and patients whose price information isn’t already available from their PBM or health plan...By improving price transparency at the point of care, prescribers can have more informed conversations with their patients and ensure they can afford the treatment they need before getting to the pharmacy counter...READ MORE

The Centers for Disease Control and Prevention reported 70,630 drug overdose deaths for 2019 in the United States, 70.5 percent of which were opioid-related...Prescription Drug Monitoring Programs are the most popular interventions states enact to address opioid addiction and overdoses...This study finds that, although Prescription Drug Monitoring Programs’ intermediary purpose to reduce prescribing has been achieved by reducing opioid distribution by 7.7 percent, they have had inconsistent effects on prescription opioid overdoses, while increasing total opioid overdoses by 17.5 percent due to increased mortality from the black market varieties by 19.8 percent...READ MORE

Drug utilization management such as prior authorization and stricter formularies cost the healthcare industry $93 billion annually, with patients bearing the largest share of the cost, a new study found...The study...found that intense use of drug utilization measures has led to patients spending $35.8 billion a year in cost-sharing...“All stakeholders in the U.S. pharmaceutical system would benefit from a de-escalation of utilization management, combining lower drug prices with lower barriers of patient access,”...READ MORE

The archaic rules of the 340B program do not ensure that it serves the vulnerable patients it was intended to help...The 340B program reached $38 billion in sales at the discounted price in 2020. This is a 27% increase over sales in 2019, and the program is now more than four times the size it was in 2014. Unfortunately, despite pharmaceutical manufacturers paying more and more money in 340B discounts, there is no evidence that this growth in 340B translates into lower costs for patients taking prescription medicines...Part of the problem is that the hospitals that participate in the 340B program have no requirements to use revenue from 340B to help needy patients afford their medicines. In fact, both the Government Accountability Office and Office of Inspector General have found that 340B hospitals often charge uninsured patients the full price for medicines for which the hospital received a 340B discount...READ MORE

In an interview with Drug Topics®, Ken Perez, MBA, vice president of Healthcare Policy and Government Affairs at Omnicell, explained the crucial points of Medicare Part B provider status for pharmacists, which would allow pharmacists in underserved communities to be reimbursed for certain primary care services that they already provide in commercially ensured populations...READ MORE

Stunning reversals, surprise delays and controversial approvals are the order of the day at the FDA lately—and doctors have had enough...Physicians’ trust in the agency is plummeting, according to a recent survey by Spherix Global Insights. More than 40% of the doctors surveyed said their confidence in the FDA has dropped over the past year...Doctors cited a range of problems—including suspected political motivations and lack of transparency...READ MORE

A new study from Accenture shows a boomerang back to a familiar topic—drug costs...“We asked what would increase trust in the pharmaceutical industry, and for many people there’s a clear link between cost and trust,”...The top two answers specifically pointed to reduced medication costs (41%) and more transparency in pricing (39%) as measures that would make the respondents trust pharma companies more...An earlier Accenture report from May suggested the new economic reality for pharma meant companies would have to work at changing the cost narrative with customers. It suggests focusing on value and outcome-based pricing to build trust...READ MORE

Researchers have created a new open-access database of information on drug candidates and how they are metabolised by the body, which could help speed up the repurposing of old drugs as new treatments...the process of developing new drugs is costly, can take decades, and often leads to failed treatments. The database, called NICEdrug.ch and described today in eLife, may help expedite the process by helping scientists find promising, existing drugs that might be repurposed...READ MORE

Raw materials and limits on high-tech equipment often take center stage when it comes to discussions around manufacturing bottlenecks. But the COVID-19 pandemic has exposed another weak link in the pharmaceutical supply chain: people...As COVID-19 vaccine production moves full-tilt, mRNA players Pfizer and Moderna are having trouble recruiting talent...Hiring challenges, which have been exacerbated by the pandemic, aren’t unique to COVID-19 vaccine makers...READ MORE