Regulators gonna regulate

This writer is confused. Is the government in the business of deregulating drug use (i.e., marijuana, i.e., the sticky icky) or regulating drug use? The FDA has announced its desire to lower the amount of nicotine in cigarettes in an effort to decrease addiction, reduce smoking, and improve health. At the same time, The Washington Post reports that the FDA is delaying its regulation of trendy smoking alternatives such as e-cigarettes, hookah, and vape thingies that all the cool kids are using. The hope is that keeping these smoking alternatives easily available and less regulated will give smokers ready access to “safer” alternatives to taking in their nicotine. Here is a list of the 20 most destructive drugs, as reported in The Economist. Yikes.

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5. Cerealization? No, serialization.

The clock is ticking on global serialization compliance. (But if you’re behind, don’t feel bad. We thought this article was going to be about breakfast foods.) As the deadline approaches, anyone selling pharmaceutical products into the U.S. will be significantly impacted if their processes do not meet regulatory standards by the end of 2017. Specifically, all products must carry a Global Trade Item Number (GTIN), serial number, lot number, and expiration date. According to Kurt Wieditz, Director/Team Leader Contract Manufacturing at Pfizer CentreOne, “Because initial serialization projects rarely go completely as planned, expect the total endeavor to take approximately 18 to 22 months.” Could be worse. You could be stuck barcoding Fruit Loops. Here’s the Wikipedia history of breakfast cereals.

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4. The crackdown continues

The city of Chicago is getting even more serious about snuffing out an epidemic that has claimed the lives of hundreds of Chicagoans so far. In a continued effort to stem opioid addiction, the city may soon require pharmaceutical sales reps to carry special licenses in order to pitch medications. “Oh just a piece of plastic to flash around, not a big deal!” the young unsuspecting sales rep might muse. Um, no. License requirements call for representatives to report back to the city on several measures including how many doctors they contact and whether these doctors receive payout. Patients and doctors can also report unethical behavior. Add this to Chicago’s record of opioid crackdowns, which includes a lawsuit filed against several drug makers’ misleading opioid marketing in June of 2014.

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3. Hikes in the right direction

Drug innovation post-pharma mergers drops faster than Ryan Lochte’s credibility post-Olympics according to a study published by the Harvard Business Review. Researchers analyzed 65 pharma deals and found that innovation declines post-merger, both within the merging companies and among competitors of the new entity. The data show that patenting and R&D spending among competitors drops by more than 20% within four years after the merger. Researchers theorize this innovation decline among competitors occurs because the merger has created one less rival competing in the same therapeutic area. Thus, less push to innovate. With increasing awareness of the impact on innovation, we’ll see if regulators are quicker to put the kibosh on future mergers.

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