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Venezuelan President Nicolas Maduro said on Friday he has asked the United Nations to help the South American nation alleviate medicine shortages, which have become increasingly severe as the oil-producing nation's economic crisis accelerates...Triple digit inflation and a decaying socialist economic model have left medications ranging from simple anti-inflammatory drugs to chemotherapy medication out of reach for most Venezuelans...The Venezuelan Pharmaceuticals Federation estimates some 85 percent of drugs are unavailable to the country's citizens...Maduro often blames the deteriorating economy and widespread shortages of goods on an "economic war" led by opposition politicians with the help of the United States...Critics say the problems are the result of dysfunctional price and currency controls that have decimated private industry.

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 cost to healthcare companies for U.S. regulatory review of their products, including drugs and medical devices, would more than double under the Trump administration's proposed 2018 budget…over $2 billion in fees to be collected by the U.S. Food and Drug Administration from industry, twice as much as in 2017...it also offered measures that would help speed up the approval process for new drugs and other products...The FDA has been charging companies to review their products since 1992. Most of the user fees collected are for prescription drugs - around $866 million estimated in 2017 - and generic drugs - around $324 million...The budget does not say if the fee increases would be evenly spread or directed in a particular area. The budget did not provide specifics on what measures to speed up approvals might include...

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...

China's FDA published a slate of suggested amendments to its foreign drug registration rules...which could dramatically revamp the country’s pharmaceutical market landscape by eliminating hurdles that slow approvals of Western drugs. Pharma companies quickly hailed the changes...the new rules would allow foreign drugmakers to file for a new drug approval using data from international, multicenter trials, so long as those trials include China as a study site. Translation: No China-specific trial applications would be required for those foreign drugs...When finalized and implemented, these policies will encourage biopharmaceutical innovation and accelerate the approval process for new medicines...They will also pave the way for China's integration into the system for multiregional clinical trials that undergirds global drug development...

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.

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…

APhA releases position on health care...the future of health care continues to be a major focus of Congress, the American Pharmacists Association emphasizes the importance of patients’ access to care, including pharmacist-provided services and safe and affordable medications. APhA Executive Vice President and CEO Thomas E. Menighan issued the following statement further explaining APhA’s position on health care:

Consistent with our recommendations related to the Affordable Care Act and other health care reforms, APhA continues to call for policies that support patient access to and coverage of —pharmacists’ patient care services, the pharmacy of their choice, and safe and affordable medications. An important component to providing access is ensuring adequate reimbursement to pharmacists for their patient care services and to pharmacies for medications and other products. Securing enactment of these policies increases access, improves quality and decreases costs...APhA strongly advocates for a health care system better structured to optimize the skills and expertise of practitioners, including pharmacists, to provide the best care to patients and value to the system…

It may have been too good to last. After an upswing in pharma's global reputation in 2015, its standing among patient groups has swung the other way—again. Only 38% of patient groups said the industry had either an "excellent" or "good" reputation, down from almost 45% last year...after last year’s peak, pharma scores dropped across all the measurements in PatientView's annual survey, including innovation, transparency, pricing, ethical marketing and high-quality, useful products...Almost all of the other healthcare segments...from biotech to insurers, also dropped in their esteem. The only exception was not-for-profit insurers.

• Blame President Donald Trump...with his very public criticisms of pharma "getting away with murder" and his vows to bring down drug prices.
• Then there's the ongoing pricing debate…
• ...another part of the reason for the overall declines may be that, as patient groups become a more important part of the healthcare conversation and infrastructure, they feel more confident speaking their minds...

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...