US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News
This article was originally published in Scrip
This past week in US regulatory, legislative, legal and political news affecting the biopharmaceutical industry included a call by President Barack Obama for ensuring there's more opportunities for women in the fields of science, technology, engineering and math, with the man in the White House declaring the US is not going to succeed if half the team members – especially when it's the smarter half – are left on the bench and not allowed to play; charges by the Generic Pharmaceutical Association and its affiliated Biosimilars Council in public comments that AbbVie Inc.'s citizen petition demanding a public hearing must be held before the FDA issues its long-awaited biosimilars guidance on interchangebility was nothing more than a "thinly disguised" ploy to block cheaper biologics that may be substituted for the brand-name products; the release of a new report by the FDA showing the agency permitted more than 700 cheaper versions of brand-name medicines onto the US market in 2015 – more than ever before; and a warning from top US health officials the Zika virus that's been spreading throughout the Americas over the past several months is "scarier" than initially thought and therefore, Congress should no longer delay Obama's $1.9bn funding request to address the situation; plus other Washington news.
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With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.
Allergan CEO Brent Saunders vows not to engage in price gouging and says his firm will limit cost increases to single-digit percentages, occurring only once per year. But it's unclear whether Saunders will stand as a lone wolf in the industry or if others will make similar pledges.
Hillary Clinton's plan to rein in high prices of older medicines, which includes creating a federal panel that has authority to impose fines, may grab headlines, but some analysts think it's unlikely to get very far in a divided Washington.