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How would a "competitive bidding process" for drugs work? We may soon find out, if President Donald Trump gets his way with the Republican healthcare bill...Trump assured supporters at a...rally that drug prices are still a top priority for him…he's working quickly to get a drug-bidding measure into the current repeal-and-replace bill...Pushing for more competition in pharma isn’t an unfamiliar refrain from the president, who highlighted his desire for bidding during an infamous pre-inauguration press conference...Trump famously said pharma is "getting away with murder."...Trump...continues to maintain that drug prices are way too high. And he often leaves industry watchers clamoring for details about proposals to bolster competition—competitive bidding included...Trump selected Scott Gottlieb to lead the FDA, who could move to boost competition by enacting changes at the agency to speed new products to market...It remains to be seen what kind of proposals might emerge, but Trump himself favors Medicare price negotiations…

Industry groups are taking aim at a rule created by the Food and Drug Administration that could restrict drugmakers' truthful and non-misleading promotion of its drugs — commonly referred to as off-label promotion — by expanding the evidence the agency can use to assert that a drug has been misbranded...For example, under the new rule — pertaining to the FDA's definition of intended use — if a manufacturer discovers that one of its products is being used off-label and, as a result, adjusts its supply and scales its manufacturing to meet higher demand for those off-label uses, the FDA could use the company's internal documents describing that intention to scale up as evidence of a new intended use...The agency expanded the definition of intended use to now include “totality of evidence.”...The new intended use rule exposes manufacturers to a significant risk of liability for conduct that is entirely lawful and beneficial to the public health...

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

India’s largest pharmaceutical firms are looking to convince U.S. President Donald Trump that his promise to lower drug costs should take priority over his vow to make sure the medicines are made in America...Savings from cheaper imported drugs will outweigh the jobs created by producing them in the U.S., the Indian Pharmaceutical Alliance...said in a report...One goal could be to win an exemption for generic drugs under any border-tax policy that is enacted in the U.S….Indian companies recommend their government highlight the firms’ investments in the U.S., where the largest companies have increased their presence in recent years in an attempt to diversify their manufacturing base...Closer collaboration with the FDA is also recommended to help the industry solve deficiencies in manufacturing practices that have prompted a wave of sanctions from the regulator in recent years, hurting the industry’s reputation and sales…..The approach should be to project India as a reliable and trustworthy source for access to safe and quality medicines at affordable prices.

The FDA has suggested an Indian API maker hire a consultant that understands FDA regulations after finding the company didn’t have a grasp of some basic requirements, including how to make sure the water that comes from a nearby river is sanitary before using it to make its products...In a warning letter to Badrivishal Chemicals & Pharmaceuticals, the FDA said its plant in Maharashtra has been using the river water since 2014 without scientific evidence that the system is capable of producing water that meets quality standards...plant employees knew the water for months was out of spec for total aerobic microbial counts when it was used in production, but they didn’t investigate or even seem to understand the process that the plant’s water system relies on to kill microorganisms...water was only one of the problems FDA investigators found...Records were found in trash bags behind a building that showed test results that were different from what had been officially recorded...

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

British drugmakers...accused Theresa May's Conservative government of breaking a manifesto commitment to improve access to new medicines, following approval of new cost rules...The angry response from both Big Pharma and biotech firms comes despite a concession by government in the latest version of the scheme, which increases the cost threshold for certain drugs for rare diseases from the previously planned level...The row comes at a sensitive time for the government, which is about to trigger proceedings to leave the European Union but wants to encourage investment by strategic industries, including the high-tech pharmaceuticals sector...Drug companies are already concerned that Brexit could make Britain a less attractive market, especially if the country ends up outside the current EU-wide system for drug licensing...The new system means that new drugs costing the National Health Service more than 20 million pounds ($24 million) a year will no longer be automatically funded, even if they are cost-effective. Instead, companies will have to enter negotiations to justify their use and work out funding...

The U.S. Department of Health and Human Services announced...that Nevada will expand mental health care services with the implementation of new community-based behavioral health care clinics...The whole idea is to try to provide better integrative care to individuals that have both substance abuse and mental disorders...We’ve never done well in this state, and probably most other states, in coordinating so that patients are getting care by the same team…the two-year Certified Community Behavioral Health Clinic...will offer 24-hour mobile crisis services, outpatient mental health and substance abuse treatment as well as recovery support.

President Donald Trump’s first budget will take $5.8 billion away from the National Institutes of Health, around 20% of its total, with FDA user fees also set to rise as biopharmas should "pay for their share."...The budget cut to the NIH...had around $30 billion in funds last year...The NIH...got a funding boost just last year when the 21st Century Cures Act was passed, a law that allowed the Institute an extra $4.8 billion in funding over the next decade...There was no direct mention of FDA cuts, but use fees are set to potentially double..Recalibrates Food and Drug Administration medical product user fees to over $2 billion in 2018, approximately $1 billion over the 2017 annualized CR level, and replaces the need for new budget authority to cover pre-market review costs. To complement the increase in medical product user fees, the Budget includes a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products...

The National Community Pharmacists Association recently requested Congressional hearings on legislation, the Improving Transparency and Accuracy in Medicare Part D Spending Act, that would stop the unfair practice of pharmacy direct and indirect remuneration (DIR) fees being applied retroactively under Medicare Part D...Retroactive pharmacy DIR fees are creating a system of winners and losers...While pharmacy benefit managers profit, the unpredictable timing and amount of these clawbacks are wreaking financial havoc on pharmacies, seniors, and taxpayers...By requiring PBMs to divulge the costs of prescription drugs for Medicare beneficiaries at the point of sale, these bills fix a problem even the Centers for Medicare & Medicaid Services acknowledges has contributed to rising costs in Medicare Part D.

• DIR fees are pushing seniors into the donut hole coverage phase faster, where seniors absorb all of the costs for their prescriptions;
• DIR fees are also pushing seniors into the ensuing catastrophic coverage phase faster, where the government's costs have risen from $10 billion in 2010 to $33 billion in 2015;
• In both of those instances, the PBMs' co-pay burden disappears, which is not the case in the initial phase of coverage;
• Independent community pharmacies' ability to plan in advance is being undermined by how PBMs currently apply DIR fees, threatening patient access to these pharmacies, especially in underserved communities; and
• All of this is occurring while PBMs continue to operate in a non-transparent manner when it comes to DIR fees.