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When Food and Drug Administration enacted the Drug Supply Chain Security Act in 2013, it set a 10-year timeline for full implementation. Well, believe it or not, we are just a little more than a year away from that November 2023 deadline...A significant portion of this last milestone requires the entire supply chain to become interoperable using secure and electronic means. One requirement that is included in Title II of the Act calls for product tracing at the package level, which had not been explored widely by the industry until recently. Our DSCSA State Regulator Pilot project tested a system for sharing this information between regulators and trading partners, including distributors, manufacturers, and others...READ MORE

...the FDA unveiled a framework to help manufacturers forge risk management plans aimed at combating drug shortages, two trade group heavyweights are sounding their discontent...the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization lobbed comments at the FDA’s draft guidance, issuing similar rebukes as those made by outfits like Civica and the Biosimilars Forum...While PhRMA said it “appreciates” the FDA’s differentiated approach to supply chain risks for varied drug products, plus the risk factors the agency has outlined,” the trade group “believes the draft guidance would benefit from a number of changes to enhance clarity for stakeholders developing and implementing [risk management plans] to mitigate drug shortages.”...BIO, meanwhile, took umbrage with certain terminology used in the FDA’s guidance alongside timing and structures for communication...READ MORE

A local pharmacy will have another chance to earn approval to sell cannabis to adults on its premises, despite the pharmacy’s proximity to a school, when the Las Cruces City Council takes on the issue at an upcoming meeting...At its Sept. 6 meeting, the council will hear an appeal from Mesilla Valley Pharmacy regarding the city Planning and Zoning Commission’s decision in April to deny the pharmacy's request to sell cannabis products. The council could vote on Tuesday to reverse that decision...READ MORE

The legislation has drawn the ire of drugmakers and industry groups alike, who contend the price negotiations are more akin to price controls. Another common refrain centers around the law’s potential to stifle biopharma innovation...But the reality may not be so bad for the industry, with the true influence of the law on biopharma companies being marginal...the legislation is set to empower Medicare to set prices for 10 medicines in 2026, with that number increasing to 60 by 2029. In 2026 and 2027, Medicare will only oversee Part D drug prices...While the bill addresses some 64 million Americans enrolled in Medicare, it fails to account for the more than 150 million Americans and their families engaged with the private insurance market...READ MORE

Nevada state police arrested a Washington state man and seized 56 pounds of suspected fentanyl with an estimated street value of $3.6 million from a vehicle a trooper stopped near the Utah line...Jorge A. Rivas-Vizcarra, 50, of Royal City was being held on multiple drug charges...in the White Pine County Jail in Ely where his bail was set at $750,000...He was arrested Monday after a traffic stop on U.S Highway 93 about 20 miles north of Ely...READ MORE

A mother and her daughter have been indicted on health care fraud charges after they allegedly received millions in false Medicare claims...Mirosis Gonzalez...and her daughter Berioska Sosa...used the pharmacy they owned and operated, Aviva Care Pharmacy, to submit over $12 million in false Medicare claims...received payments totaling about $8.4 million...The marketing and telemedicine companies recruited patients and referred Medicare beneficiaries and doctors’ orders and prescriptions to Aviva Care Pharmacy and were paid kickbacks and bribes in return...the companies sent Aviva orders, which the pharmacy accepted...“without considering medical necessity or Medicare reimbursement eligibility.”...They are accused of disguising the kickbacks and bribes they paid to these companies by saying the payments were for marketing and other services...READ MORE</strong>

In another opioid-related settlement for Johnson & Johnson, the company has agreed to pay tens of millions of dollars to settle litigation in New Hampshire...The state sued the company back in 2018, alleging that J&J's subsidiaries “aggressively marketed” opioid painkillers and falsely hawked them as safer than alternatives. Now, just before a trial was set to begin next week, J&J agreed to pay the state $40.5 million...READ MORE

After more than two decades of violating state law, the Nevada Board of Pharmacy must remove cannabis from a list of controlled substances deemed to be highly abused, a Clark County District Court judge ruled...The order followed a lawsuit brought forward in April by the Cannabis, Equity and Inclusion Community on behalf of Antoine Poole, a Las Vegas resident who was convicted of felony possession of a controlled substance for marijuana in 2017. The conviction occurred the same year recreational marijuana use became legal in Nevada...READ MORE

The Alabama Attorney General’s office is investigating the Alabama Pharmacy Board after it revoked the license of a north Alabama pharmacist for working without permission after a felony conviction...Attorney General Steve Marshall’s office dismissed the board’s case against pharmacist Billy Flint East, whose license was taken in March...“Credible allegations have been made about the handling of this matter by employees of the State Board of Pharmacy, which are now under investigation by the Attorney General’s Office,” said the state order...Marshall’s office similarly dismissed the board’s case against East’s current employer, Brooklere Pharmacy, after the Pharmacy Board alleged it did not seek legal approval for East to practice after his conviction...READ MORE

Bayer AG agreed to pay $40 million to resolve US lawsuits linked to allegations that company officials bribed hospitals and physicians to use its drugs...The settlement stems from two “whistle-blower” suits filed by ex-marketing employee Laurie Simpson almost two decades ago and subsequent litigation by the US government, the US Justice Department said...in a statement. Simpson will receive about $11 million from the settlement, the department said...READ MORE