PHARMACY

FDA takes aim at online pharmacies

BY David Salazar

SILVER SPRING, Md. — Working with international law enforcement agencies and regulators, the Food and Drug Administration recently acted against some 500 websites selling illegal and unapproved versions of such prescription drugs as opioids, epinephrine injections and antibiotics directly to American patients.

“These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including counterfeit medicines and controlled substances,” FDA commissioner Dr. Scott Gottlieb said. “Consumers go to these websites believing that they are buying safe and effective medications, but they are being deceived and put at risk by individuals who put financial gains above patient safety.”

The actions —including warning letters to the operators of targeted sites and the confiscation of certain websites in partnership with internet registrars — were part of Operation Pangea X, led by Interpol as part of the 10th International Internet Week of Action, which seeks to combat the illegal online sale and distribution of possibly counterfeit or substandard medical products.

“The ease with which consumers can purchase opioid products online is especially concerning to me, given the immense public health crisis of addiction facing our country,” Gottlieb said. “Some of the websites sold unapproved versions of multiple prescription opioids directly to U.S. consumers. This easy and illegal availability of these controlled substances fuels the misuse and abuse of opioids.”

As part of the agency’s broader effort to fight illegal online pharmacies, Gottlieb said the FDA is developing a comprehensive Enforcement Operations Work Plan aimed at combating foreign unapproved drugs being sold to U.S. consumers and increasing the scope of the agency’s operations related to these operations. 

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Cardinal Health’s Giacomin re-elected as HDA board chairman

BY David Salazar

ARLINGTON, Va. — The Healthcare Distribution Alliance will be retaining Cardinal Health pharmaceutical segment CEO as its board chairman. The organization on Tuesday announced Jon Giacomin’s re-election to the position he has served in since 2016. Also continuing in his position on the board is vice chairman Henry Dale Smith, Jr., who is chairman and CEO of Smith Holding Co.

“HDA is pleased to welcome back Jon and Dale —their steady leadership will help shape the Alliance’s efforts to promote the critical role of pharmaceutical distributors, whose expertise ensures the safety and efficiency of the supply chain every day,” HDA president and CEO John Gray said.

In addition to Giacomin’s and Smith’s re-election, HDA appointed three new members — HPC Rx CEO Fred Battah, CuraScript SD president Earl English and Principal Dynamics CEO and Quality Care Products CEO Michael Holmes.

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Teva relaunches Depo-Provera generic

BY David Salazar

JERUSALEM — Teva is reintroducing its generic of Depo-Provera (medroxyprogesterone acetate injectable suspension, 150 mg/mL) contraceptive injection. The drug is indicated to prevent pregnancy.

“This reintroduction brings an additional product to a market that was previously lacking in options,” Teva EVP and president of global generics research and development Dr. Hafrun Fridriksdottir said. “In addition to its importance to patients who will benefit from access to this medicine, this reintroduction holds significant importance to Teva and our generics R&D priorities.”

The reintroduction adds to Teva’s generic injectable business, which the company has been focused on growing. The drug had U.S. sales of approximately $211 million, according to QuintilesIMS data for the 12 months ended July 2017.

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