Author: Peter

The fight over how biosimilars should be named in the US isn’t over yet despite the Food and Drug Administration’s use of a non-proprietary name with a random suffix for the second approved biosimilar and plans to do the same for all future biosimilars...The group of nonprofits and other stakeholders, spearheaded by the Alliance for Safe Biologics, requested in a letter that FDA use meaningful suffixes for biosimilar non-proprietary names, such as the one used with the first biosimilar approval for Zarxio (filgrastim-sndz). The group said meaningful suffixes are preferable to the random suffixes described in the FDA’s draft guidance on biosimilar naming...In that draft guidance, FDA said the meaningless suffixes will help prevent inadvertent substitution (which could lead to medication errors) of biologics that are not determined to be interchangeable by the FDA..."Meaningful suffixes are easier for patients, providers and pharmacists to both recognize and remember, thus facilitating accurate association between adverse events and specific products."

Moves in Congress to link billions of dollars in new medical research funding to revised standards for drug and medical-device approvals are troubling some public-health experts, who say the combination makes it too easy for lawmakers to support lower patient-safety standards...These safety advocates say legislation to beef up research funding for the National Institutes of Health should be separated from product-approval changes at the Food and Drug Administration..."This is the first time this has been done this way, and it’s a deal with the devil," said Dr. David A. Kessler, onetime FDA commissioner during the 1990s under presidents of both parties. "It’s time to uncouple the promise of research funding from the requirement that FDA standards be lowered."...To its supporters, linking NIH funding with FDA bills (21st Century Cures Act)—including changes to approvals of antibiotics and some medical devices—produces innovation in life-saving products and research. Politically, it is a classic Washington bargain that has something for everyone...The new FDA commissioner, Dr. Robert M. Califf, said in a recent talk that "this legislation, if not carefully crafted, could pose significant risks for FDA and American patients…Innovative therapies are not helpful to patients if they don’t work, or worse, cause harm," he said...

Serious side effects associated with fluoroquinolones generally outweigh the antibiotics’ benefits for patients with uncomplicated infections like sinusitis and bronchitis…the FDA determined that systemic use of fluoroquinolones is associated with "disabling and potentially permanent serious side effects that can occur together" involving the tendons, muscles, joints, nerves, and central nervous system...The alert comes a year after the FDA convened an advisory committee to review the risk-benefit balance for fluoroquinolones...the risk wasn’t worth the potential benefit for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections, for which other treatment options exist...Labels and medication guides for all fluoroquinolones will be updated to reflect the FDA’s findings...

The US Food and Drug Administration is paid fees by the pharmaceutical industry to review brand-name and generic drugs. Now, the agency wants to collect money to review over-the-counter medicines...Specifically, the agency wants companies to pay for reviewing OTC monographs. Unlike brand-name and generic drugs, which involve individual companies seeking approval to market individual drugs, the OTC monographs refer to multiple medicines that share the same ingredient for the same use. Moreover, numerous companies can make these drugs, but do not require FDA approval prior to marketing...the pharmaceutical industry has largely supported so-called user fees...the fees helped transform the relationship between companies and regulators, who are under increasing pressure to meet benchmarks for speeding applications through the review process...Given the workload, the FDA argued that user fees will only bolster its ability to review OTC medicines…the large OTC companies interested in a modernized system who will support it in exchange for some concessions from FDA...The smaller, more fragmented (companies) will probably oppose it as (fees represent) more regulatory burden on them in an area that has worked for decades without fees

Pfizer Inc has taken steps to ensure that none of its products are used in lethal injections..."We are enforcing a distribution restriction for specific products that have been part of, or considered by some states for, their lethal injection protocols," the...drugmaker said on its website. "Pfizer strongly objects to the use of its products as lethal injections for capital punishment."...The move shuts off the last remaining open market source of drugs used in executions, following similar actions by more than 20 U.S. and European drugmakers, according to a report in the New York Times...Pfizer’s distribution restriction limits the sale of the seven products to a select group of wholesalers, distributors, and direct purchasers under the condition that they will not resell these products to correctional institutions for use in lethal injections, the company said.

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The 21st Century Cures Act will have a huge impact on the pharmaceutical industry nationally and globally...All of the major pharmaceutical companies target the United States...they will have to comply with the...Act (when passed)…Precision medicine, meanwhile, is a programme announced...last January...it is an emerging approach for disease treatment and prevention, which includes a patient’s variability in their genes, environment, and a person’s lifestyle...What has the precision medicine initiative got to do with the 21st Century Cures Act?.. Precision medicine would allow the inclusion of much more technology driven healthcare innovation and would permit the introduction of additional personal data and information into health science...The requirement to get drugs to market faster is evident. However, a lack of interoperability poses a huge challenge when it comes to getting patient data consolidated in time for clinical trials...A large part of the new legislation is aimed at trying to connect the research and development arms of life science companies to health IT or digital health specialists...all pharmaceutical companies will benefit from the Act as they will be able to get their drugs out faster. On the technology side, the major beneficiaries of the Act will be the big data analytics players, since this lies at the heart of speeding up approvals...The good news is most (if not all) of the major players are fully aware of the challenges and opportunities of the Act.

It is "highly uncertain" how much money the state of California would save if a ballot measure to cap drug prices passes in November — and it might not save money at all. That’s the key finding in a preliminary report by the Legislative Analyst’s Office...The ballot initiative, known as the Drug Price Relief Act, would prohibit the state from paying more for a prescription drug than the lowest price paid by the U.S. Department of Veterans Affairs...But the financial impact on the state is unclear, the analyst’s office said, for two reasons.

• One, the lowest prices paid by the VA are not known and there’s no guarantee they will be revealed to the public — or to state officials.
• Two, it’s unclear how drug companies would react if the measure became law: The companies might, for example, raise prices on the VA, nullifying the intended effect.

"This measure is misleading and unworkable," Hollaine Hopkins, executive director of the Lupus Foundation of Southern California, said in a prepared statement. "It will lead to increased red tape and bureaucracy, and could actually increase costs for the state’s taxpayers."...Opponents of the measure had raised more than $58 million as of May 4, according to the California Fair Political Practices Commission. The AIDS Healthcare Foundation has raised a little more than $4 million in support of the initiative.

If it’s been a while since you've taken the North American Pharmacist Licensure Examination (NAPLEX), test yourself on these NAPLEX questions to see how well you’d do on the test today.

A judge has unsealed records from a Kentucky lawsuit against the maker of the prescription painkiller OxyContin, including the secret testimony of a former company president...Pike Circuit Court Judge Steven Combs ordered the records be released in 32 days. But Combs said he would delay his order if Purdue Pharma appealed the decision...OxyContin is a powerfully addictive prescription painkiller that was marketed for its ability to slowly release its effects over a 12-hour period. The company suggested this long-acting formula made it less addictive and safer for patients. But users quickly found the pill lost its time-release qualities if it was crushed, resulting in an instant high...In 2006, the company agreed to plead guilty and pay more than $630 million to settle federal charges that it misled doctors and patients about the risks of its top-selling drug...The judge in the case agreed to seal any records Purdue Pharma marked as confidential. Statnews.com...sued to have the records released once the case was resolved. They are particularly interested in Sackler's testimony, as it could reveal how much the company knew about how addictive OxyContin truly is...Lawyers for Purdue Pharma said the company agreed to hand over documents and give Kentucky's attorneys access to high level company officials because it believed the documents would never be made public. They argued that releasing the documents now would betray that trust and bog down the state's civil court docket.