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Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

The US FDA and the European Union took an important step forward this week in pharmaceutical manufacturer inspection collaboration, completing an exchange of letters that will allow the FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other’s borders...the letters, which will amend the Pharmaceutical Annex to the US-EU Mutual Recognition Agreement, will enable the FDA and EU to "avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk...The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective and high quality drugs…

India’s largest drugmakers are making a case that the U.S. should import cheap Indian-made drugs to hold down healthcare costs, and partner with its pharma leaders to develop inexpensive biosimilars. But Indian pharma companies have a less-than-stellar track record with the FDA on manufacturing quality, and that is casting a cloud over the country’s efforts to partner with President Donald Trump as he pushes to lower drug prices...The Indian Pharmaceutical Alliance made its viewpoints on drug importation clear in a report released recently...The organization...suggested the U.S. would save more by importing inexpensive drugs than it would by boosting domestic manufacturing in an effort to create jobs.

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Ned Milenkovich, PharmD, JD, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

For people living in rural areas of the U.S., access to health care providers can be a serious challenge. Pharmacists can be part of the solution. And in a welcome show of bipartisanship, Republicans and Democrats in Congress are co-sponsoring legislation that can help...The Pharmacy and Medically Underserved Areas Enhancement Act...would include pharmacists on the list of recognized health care providers that can be reimbursed by Medicare for providing much needed patient care in underserved areas. USP supports this legislation as a major step forward in improving health care. Here are three reasons why:

• Pharmacists are highly trained health care professionals
• Pharmacists are easily accessible to patients
• Pharmacists improve health care

As lawmakers began a detailed review of the state mental health budgets on Friday, speakers asked them not to cut services to the mentally ill, but rather to reinvest the money where critical needs continue to exist...a Joint Senate Finance and Assembly Ways and Means subcommittee took a look at the funding proposals for mental health services, which are proposed to see some state general fund spending reductions in the coming two years...Southern Nevada Adult Mental Health Services, state general fund support would decrease from $93 million in the current budget to $83 million in the new spending plan, with the loss of 38 staff...Northern Nevada Adult Mental Health Services, the general fund budget reduction is from $32 million to $26 million with the loss of 56 positions...Officials with the Division of Public and Behavioral Health told lawmakers that funding for mental health programs is increasing, but services being provided from the state general fund are being shifted to the Medicaid program with an expansion under the Affordable Care Act. Medicaid costs are shared by the state and federal governments...Private sector psychiatric hospitals are also being built to provide treatment to the mentally ill because many are now Medicaid eligible and do not have to be treated in state-funded hospitals...

National Football League teams violated federal laws governing prescription drugs, disregarded guidance from the Drug Enforcement Administration on how to store, track, transport and distribute controlled substances, and plied their players with powerful painkillers and anti-inflammatories each season, according to sealed court documents contained in a federal lawsuit filed by former players...testimony and documents by team and league medical personnel, describes multiple instances in which team and league officials were made aware of abuses, record-keeping problems and even violations of federal law and were either slow in responding or failed to comply...

• Disregarding federal laws
• Reliance on pharmaceuticals
• Lining up for the ‘T Train’

Senators Bernie Sanders, Cory Booker, and Bob Casey introduced a new bill this past week that would allow the importation of prescription medications from licensed Canadian pharmacies. The legislation, named the Affordable and Safe Prescription Drug Importation Act, would permit the United States to import medications from Canada, where drug spending is significantly lower…The bill outlines importation provisions including safeguards and consumer protections, such as FDA certification of foreign sellers, a clear definition of what drugs may be imported, and supply chain security requirements. Imported drugs must have the same active ingredient, route of administration, and strength as its US-approved counterpart...Previous importation proposals have been shot down due to safety concerns, but supporters of the new bill note added safety measures…Pharmaceutical Researchers and Manufacturers of America released a statement condemning prescription drug importation, due to the potential of counterfeit drugs entering the United States that could put American patients at risk...Even drugs that supposedly come from Canada are frequently not made or processed there, but actually come from counties with lax regulatory systems.

The pharmaceutical industry’s growing interest in orphan disease shows no sign of diminishing, and for good reason. The increased R&D investment in these indications in recent years has translated into a growing share of overall pharmaceutical sales...The drivers of this change include the favourable regulatory treatment of orphans, as well as market exclusivity and pricing advantages that make such drugs much more profitable than non-orphans. It is notable that the top 25 non-oncology orphan drugs in 2022 are expected to show a compounded growth of 18% over the next six years, almost three times the wider market average...Orphans...remain one of the brightest spots of pharmaceutical development, and the legislation framing them is widely claimed to have been a great success in public policy terms. However, there is a risk that before long orphans could face the same sort of pricing pressure as is common in non-orphan indications...