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Drug Enforcement Administration...announced...Dr. Francisco Huidor-Figureoa, 48, a physician...Montgomery, Alabama, pleaded guilty...to one count of conspiring to distribute oxycodone and one count of conspiring to commit money laundering...During the plea hearing...Figureoa admitted that he worked...a “pill mill.”...was the sole physician employed by the EMED Medical Management Corporation...in Opelika, Alabama...Figureoa sold oxycodone to pill dealers, based on a fraudulent prescription...knew that the recipients of these illegal pills did not need the medicine and that the recipients intended to either abuse the pills or sell the pills to others who would abuse them...Figueroa faces up to 20 years’ imprisonment on each count...Additionally, on the drug distribution conspiracy count...faces a maximum fine of $1,000,000.  On the money laundering conspiracy count, the maximum fine...could be...$500,000, or twice the value of the property involved in the transaction, whichever is greater.

The government of China continues to refine its legal powers to deal with drug safety issues, according to a release from the country's Supreme Court that says investigations will be streamlined to identify administrative cases that potentially involve major criminal breaches...The new measures are designed to "facilitate coordination between administrative and judicial organs in handling food and drug safety cases," according to a report from the Shanghai Daily...The China Food and Drug Administration and the Ministry of Public Security, the Supreme People's Court, the Supreme People's Procuratorate and the executive office of the food safety commission under the State Council, China's cabinet, said the measures will "streamline" standards and procedures and will include the possibility of suspected drug cases being transferred from administrative bodies such as the CFDA to police...These latest moves are an attempt by Chinese officials to bring trust to the "Made in China" label because most Chinese prefer foreign-made drugs which they believe are higher quality. Several Chinese and Indian companies in recent months have been slammed by regulatory authorities in the United States and Europe over lapses in good manufacturing practices and outright fraud in many cases where test results were falsified.

As the nation’s retail pharmacies move deeper into the business of providing healthcare services, they now want pharmacists to be paid by Medicare to immunize the nation’s seniors....Under legislation that is gaining rare bipartisan support and momentum in the House and Senate, particularly for a Congressional health bill, pharmacists would be paid to administer vaccines under Medicare part B...The pharmacies have formed a coalition known as “The Patient Access to Pharmacists’ Care Coalition,” to push for the legislation, known as the Pharmacy and Medically Underserved Areas of Enhancement Act (S. 314/H.R. 592). The coalition includes retailers and grocery store chains with pharmacies such as Walgreens Boots Alliance , CVS Health, Wal-Mart, Kroger, Rite-Aid and Target...It could bring in hundreds of millions of dollars to the drugstore industry given the growing business of providing vaccinations.

Several pharmacists and former pharmacists have been recognised in the New Year’s honours list, with four being made Officers of the Order of the British Empire...

• Bill Scott, Scotland’s former chief pharmaceutical officer ...recognised for services to healthcare.
• Norman Morrow, chief pharmaceutical officer for Northern Ireland...was recognised for his contribution to pharmacy.
• David Cowan, professor of pharmaceutical toxicology and director of the drug control centre at King’s College London...was recognised for services to anti-doping science.
• Alan Willson, who began his career as a pharmacist, was honoured for services to the quality and safety of healthcare in Wales.
• Zameer Choudrey — was made a Commander of the Order of the British Empire in recognition of his contribution to the UK wholesale industry.

Docket Alarm’s new suite of tools has components that help give Orange Book litigators a competitive edge…the first legal research platform to provide Orange Book litigators a suite of tools for their practice. The features include the ability to track changes to the Orange Book and related litigation, search correspondence between drug companies and the FDA, and analytics on Orange Book cases in the Patent Trial and Appeal Board…The "Orange Book,"…is the authoritative resource on FDA approved drugs for patent litigators. When a drug company wins FDA approval for a new drug, they submit an Orange Book listing detailing applicable patents covering the new drug and the drug’s labeling. Generic drug manufacturers engage in patent litigation with the branded company over whether the patents listed in the Orange Book are valid and properly cover the corresponding drug.

If there is a surefire way to arouse the concerns of Food and Drug Administration inspectors, try this: take a notebook listing manufacturing problems, place it in plastic bags along with other paperwork, and toss them in a nearby scrap yard where the inspectors can find them...Here’s another approach: leave “unofficial notebooks,” which are used to track manufacturing activities, lying around an office so the inspectors can read how bacteria is present in the water system, but become puzzled when the problem is not cited in official company records...These were just two of several “serious breaches” of good manufacturing practices the FDA cited in a Dec. 23, 2015, warning letter sent to Cadila Healthcare...What else concerned the FDA?

• There were problems with the potency of warfarin made at one plant and Cadila agreed to temporarily suspend production.
• ...nine consumer complaints were lodged by way of pharmacies and distributors over potential product mix-ups.
• Several batches of active pharmaceutical ingredients failed an analysis, but Cadila never explored why this occurred.

The New Year is here—let’s kick it off with some good news/bad news for pharmacists...According to our...analysis of the Bureau of Labor Statistics’ new Occupational Outlook Handbook, drugstores are projected to employ about 7,000 fewer pharmacists in 2024 than they do today...The good news? Pharmacists jobs in non-retail settings—hospitals, doctor’s office, and clinics—will add more jobs than the ones lost from retail...Employment will increase at other outpatient dispensing formats, with mail pharmacies experiencing the largest percentage increase..."Demand is projected to increase for pharmacists in a variety of healthcare settings, including hospitals and clinics. These facilities will need more pharmacists to oversee the medications given to patients and to provide patient care, performing tasks such as testing a patient’s blood sugar or cholesterol…Employment of pharmacists in traditional retail settings is projected to decline slightly as mail order and online pharmacy sales increase."

After nearly three years of sparring with a recalcitrant compounder, the Food and Drug Administration has filed a lawsuit asking a federal court to prevent Downing Labs from continuing operations. And the compounder agreed to a consent decree, which requires the company to take various steps before operations can resume...In the lawsuit, the agency cited numerous violations of so-called good manufacturing practices and several issued warnings to the company...about its failure to comply with regulations. Most recently, the Dallas-based compounder, which in 2014 refused to an FDA request to recall some products, failed yet another FDA inspection...the FDA inspectors found unsanitary conditions, according to the lawsuit...tests...found traces of...bacteria which, “if introduced into the body, can cause septic shock, pneumonia, and urinary tract infections,” the lawsuit stated...the Drug Quality and Security Act was passed to, in part, bolster compounding oversight. In fact, the FDA cited the defiant posture taken by Downing as an example of why a new law was needed to allow the agency to bolster its oversight and pursue legal options when compounders refused to upgrade operations.

In the latest skirmish over prescription drug pricing, consumer activists filed a lawsuit against Ohio officials for ordering a review of signatures collected for a ballot measure designed to lower the cost of medicines...The proposed measure, known as the Ohio Drug Price Relief Act, would require the state to pay no more for medicines than the Department of Veterans Affairs. Currently, the VA gets a 24 percent discount off average manufacturer prices. A similar measure recently qualified for the ballot in California, despite opposition from the pharmaceutical industry...The lawsuit was filed two days after Ohio Secretary of State John Husted demanded election officials conduct another review of more than 171,000 signatures. He took that step after attorneys for the Pharmaceutical Research & Manufacturers of America, the industry trade group, wrote a letter to Husted to question the validity of many of the signatures that had been submitted...Drug makers are not taking any chances. In California, for instance, a spokeswoman for the industry campaign to defeat the ballot initiative recently called the proposal “misleading and flawed.”...She also argued the measure will increase the prices of prescription drugs sold to veterans and many California consumers, and reduce choices of medicines available. At the same time, she maintained the measure will cost taxpayers “millions more in state bureaucracy and lawsuits because it will be virtually impossible to implement.”

Dr. Reddy’s Laboratories is feeling blue over a purple pill...The generic drug maker last week agreed to change the color of its new version of the Nexium heartburn medicine from purple to blue in order to settle a lawsuit that was filed by AstraZeneca....For more than two decades, AstraZeneca has capitalized on a marketing campaign that labeled its two widely prescribed heartburn drugs — first, Prilosec and then Nexium — as “the Purple Pill.” But after Dr. Reddy’s last September began selling a lower-cost generic version, which resembled the brand-name drug, AstraZeneca claimed the Indian drug maker was ripping off its trademark look...