Chicago Will License Pharma Sales Reps to Fight Opioid Overprescribing

Chicago will enact a new requirement that all pharmaceutical sales reps maintain a license based on their training for ethics, marketing regulations and industry laws; at a cost of $750, the reps will be responsible for applicable fees and annual renewals. The new ordinance also requires paperwork to be filed with the city regarding the reps’ activities and physician contact. The new regulations come after Chicago filed lawsuits against multiple drug manufacturers and their role in the current opioid epidemic. The fees are expected to exceed $1 million for the city, which will then be used to support ongoing education efforts, regulatory costs and expanding treatment availability for addicts. The pharmaceutical industry argues that the new requirements do nothing to curb opioid abuse.

Read a Stat News article on it here.

[Medscape Podcast] Biosimilars: Can They Be Trusted?

Podcast summary: The first biosimilars were released in Europe ten years ago and were based on biologics with fairly simple structures. As technology and understanding expands, manufacturers are approaching a more complex set of drugs; some critics worry that, while researchers are able to easily map the sequence of proteins, the actual structure of a biosimilar may have slight, undetected variations from its counterpart. Industry experts, however, are confident that the advancement of the technology used to compare the chemical makeups is so precise that any undetected structural error would be too minor to impact the drug’s efficacy or safety. Additional concerns stem around clinical trial requirements – while the original biologic required rigorous testing with thousands of people, trials to prove equivalence (rather than efficacy) are typically much smaller in nature. On the other hand, equivalence studies are much more affordable, lending this approach to the cost containment initiatives that make biosimilars attractive in the first place. Further, regulatory agencies will also likely require extensive additional evidence of drug similarities, supplementing required trials, before any approvals are issued.

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