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U.S. health regulators are telling drugmakers to immediately pull their popular heartburn drugs off the market after determining that a contamination issue with the medications poses a greater risk than previously thought...The move from the Food and Drug Administration Wednesday applies to all prescription and over-the-counter versions of ranitidine, best known by the brand name Zantac. The drugs are widely used to treat stomach acid and ulcers...Dozens of recalls have been linked to the same probable carcinogen since last year. The FDA is still investigating the issue and has sanctioned at least one manufacturing plant in India that makes ingredients used in the medications...READ MORE

During this COVID-19 pandemic, the FDA is working around the clock to make sure that Americans have access to safe food and medical products. The agency is continuously examining the global supply chain to identify any concerns and assess the availability of the products Americans need most. We are also partnering with the Federal Emergency Management Agency (FEMA) on supply chain issues, including importation of needed medical products to support the U.S. response. Here is a status update and details on some of the latest actions we have taken:...READ MORE

Medical Devices

Human Drugs & Biologics and Animal Drugs

Blood Supply

Human and Animal Food

Veterinary Medicine

Here are seven things you may have missed in the enormous $2 trillion economic stimulus package...includes major requirements for insurers to cover diagnostics and services associated with COVID-19 and gives some flexibility to hospitals...But the bill, which includes massive unemployment assistance and help to businesses, includes several other healthcare provisions...READ MORE

1. Requiring Medicare Part D and Medicare Advantage plans to allow for refills and fills for up to three months.
2. Extending healthcare programs through November.
3. Waiving site-neutral payment cuts, 50% rule for long-term care hospitals.
4. Eliminating Medicare sequester and boosting Medicare payments for COVID-19 payments.
5. Requiring payers to cover hospital-made tests.
6. Publishing the cash price for diagnostic testing.

Requiring group and individual health plans to cover preventive services.

In the recent flap over chloroquine and its relative hydroxychloroquine, drugs seen as promising in many quarters for use in treating COVID-19 patients, one commentator typical of many sternly proclaimed that these compounds “have NOT been proven effective against” the novel coronavirus. Implication: These are drugs no reasonable person would want to take, nor a reasonable doctor prescribe...And yet, as Arizona physician Jeffrey Singer notes, “Doctors around the globe, including the U.S., are using these and other drugs to treat their patients, and reporting on their findings in the peer-reviewed medical literature.” It’s both legal and utterly routine for doctors to prescribe a drug for indications other than the one for which it has been approved — so-called “off-label prescribing.”...In fact, an estimated 20% of pharmaceuticals reach patients that way. And this will be true almost by definition for a newly emergent malady, for which there will be no compounds proven effective yet...READ MORE

The U.S. Food and Drug Administration said malaria drugs hydroxychloroquine and chloroquine are in shortage due to a surge in demand because of the coronavirus pandemic...The drugs, which have been tried with some success to treat the illness caused by the virus, were added to the agency's website that lists drug shortages on Tuesday...Studies are underway in a number of countries to see whether hydroxychloroquine and the related malaria drug chloroquine may be effective in controlling the spread of coronavirus, which has led to a surge in demand for the treatments...READ MORE

The Food & Drug Administration has authorized the use of two drugs championed by President Donald Trump as a means to fight coronavirus...On Sunday night the FDA issued an emergency authorization for the use of two anti-malaria drugs, hydroxychloroquine and chloroquine. Researchers in the United States have begun testing the drugs in some states, like New York, but the drug will now be more widely available...The FDA has allowed for the drugs to be “donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible,” the department of Health and Human Services said in a statement...READ MORE

Anthem faces a federal lawsuit for submitting inaccurate diagnostic data to get a higher Medicare reimbursement...The U.S. Attorney for the Southern District of New York said in the lawsuit...that Anthem failed to find and delete inaccurate diagnosis codes from 2014 to early 2018 through its “chart review program,”...“By ignoring its duty to delete thousands of inaccurate diagnoses, Anthem unlawfully obtained and retained from [Centers for Medicare & Medicaid Services] millions of dollars in payments under the risk adjustment payment system for Medicare Part C,” the lawsuit said...READ MORE

As part of the Trump Administration’s all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.,,READ MORE

Associations representing generic drug makers, health insurers, pharmacy benefit managers and pharmacies have sent a letter to top administration and congressional leaders laying out how some policies and proposals to fight COVID-19 are making the situation worse...In an unusual display of coordinated frankness for the industry, a coalition representing generic drug makers, insurers, pharmacies and benefit managers told Vice President Mike Pence and congressional leaders that some policies in place or under consideration to fight COVID-19 are making it difficult and more expensive for patients to get some drugs...Signers of the letter are the Academy of Managed Care Pharmacy, America’s Health Insurance Plans, the Association for Accessible Medicines, the Blue Cross Blue Shield Association, the National Association of Chain Drug Stores, the National Association of Specialty Pharmacy, the Pharmaceutical Care Management Association and Pharmaceutical Research and Manufacturers of America...READ MORE

340B Health today asked the federal government to extend regulatory flexibility and financial support to safety-net hospitals participating in the 340B drug pricing program. In a pair of letters to leaders of the U.S. Dept. of Health & Human Services, 340B Health requested a series of policy changes under the public health emergency caused by the Coronavirus disease 19 pandemic...In a letter to HHS Secretary Alex Azar, 340B Health asked that the department take five key actions:

1. Delay implementation of a proposed survey of 340B hospitals on their drug acquisition costs so hospitals can focus on combating the pandemic;
2. Suspend the nearly 30 percent Medicare Part B payment reduction to 340B hospitals so these providers have the resources they need during this crisis;
3. Allow hospitals subject to the group purchasing organization (GPO) prohibition to purchase covered outpatient drugs through a GPO without the usual documentation requirements so hospitals can access drugs during the public health emergency that are subject to shortages;
4. Waive the Medicare disproportionate share (DSH) adjustment percentage requirements so hospitals currently participating in 340B won’t lose program eligibility due to their treatment of COVID-19 patients; and
5. Waive the quarterly enrollment periods to allow open registration for 340B-eligible covered entities, child sites, and contract pharmacies so safety-net providers can access the resources they need for their pandemic response.

“These steps would provide safety-net hospitals with much-needed assistance and flexibility to focus their attention on the growing patient treatment needs presented by COVID-19,”...READ MORE