With Drug Quality and Security Act, federal government sticks its nose where it’s needed
On Nov. 18, the Senate passed by voice vote the Drug Quality and Security Act, sending to president Barack Obama’s desk legislation that implements federal tracking and tracing of drugs and strengthens federal regulations on pharmacy compounding.
The bipartisan bill, which has the support of such trade groups as the National Association of Chain Drug Stores, the National Community Pharmacists Association and the Generic Pharmaceutical Association, ties up a couple of problematic loose ends in the pharmaceutical supply chain, namely the so-called "downstream" supply chain, which refers to the path that drugs take from their manufacturers to providers and patients, as well as sterile compounding.
The federal government already regulates the "upstream" supply chain – between manufacturers and their suppliers – but the downstream supply chain has long been regulated through a patchwork of state regulations that allows criminals to sneak counterfeit and adulterated drugs into the national supply chain through states with the laxest regulations. Without such inconsistencies, criminals will no longer find it easy to exploit the system.
The regulations concerning compounding pharmacies are important because they allow regulation of compounding of medicines for individual patients – which takes place at many pharmacies, including retail pharmacies – to continue happening at the state level, distinguishing it from large-scale sterile compounding of more complex medicines like injectables. In this way, the bill codifies the clear distinction between common pharmacy services and the kinds of activities that transform pharmacies into drug manufacturers.
In other words, the federal government is sticking its nose exactly where it needs to – in areas where patients’ safety has already been compromised on a large scale around the country and where risk has crossed state lines, sometimes with deadly consequences – and keeping it out of where state regulations are adequate.
FDA gives regular approval to Pfizer’s Xalkori
NEW YORK — The Food and Drug Administration has granted regular approval to a new drug made by Pfizer for treating a form of lung cancer, the drug maker said.
Pfizer announced the approval of Xalkori (crizotinib) for anaplastic lymphoma kinase-positive non-small cell lung cancer that has spread to other parts of the body, as detected through testing. Lung cancer causes an estimated 1.4 million deaths around the world each year, according to the International Agency for Research on Cancer. According to Pfizer, more than 6,000 people globally have been treated with Xalkori, including those who received it in clinical trials, while Pfizer estimates that rates of testing for ALK in U.S. lung caner patients are more than 60%.
"Xalkori has dramatically changed the treatment landscape for patients with advanced ALK-positive NSCLC," Pfizer Oncology Business Unit president and general manager Garry Nicholson said. "Achievement of this milestone underscores Pfizer’s commitment to provide physicians with effective cancer therapies for their patients."
Diplomat added to limited-distribution network for Cornerstone Therapeutics’ Bethkis
FLINT, Mich. — Cornerstone Therapeutics has added specialty pharmacy Diplomat to its limited-distribution network for a newly approved treatment for cystic fibrosis, Diplomat said Friday.
Diplomat will distribute Bethkis (tobramycin inhalation solution), which received Food and Drug Administration approval in October for treating chronic bacterial lung infections caused by P. aeruginosa in cystic fibrosis patients.
Cystic fibrosis affects more than 30,000 children and adults, according to the Cystic Fibrosis Foundation, with 1,000 new cases diagnosed each year.
Correction: The original statement from Diplomat incorrectly referred to the name of Cornerstone Therapeutics. This version of the story corrects the original.