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Legislation

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Latest From Legislation

Running The Gauntlet: Takeaways From The First Round Of HHS Hearings In 2019

Release of the White House budget proposal kicked off the first round of hearings on HHS with a new Democratic majority in the House and a new HHS budget czar in the Senate. HHS Secretary Azar did his best to set a constructive tone for advancing drug pricing policies – and maintaining his own position – in the year to come.  
Legislation Leadership

FDA Aims For Greater Role In Pharma Business Continuity Planning

Legislative proposals described in the US FDA’s FY 2020 budget request justification document would give the agency more authority to oversee business continuity planning at pharmaceutical companies with the idea of preventing shortages of essential drugs.

Manufacturing Quality

Measles Hearings Offer Counterpoint To Pricing Spotlight: Vaccines Touted As Cost-Effective Solution To Outbreaks

Congressional hearings on the recent outbreaks of measles and other vaccine-preventable diseases offered a positive theme for the industry during the ongoing drug pricing debate.

Legislation Drug Safety

Opioids, Old Initiatives Dominate FY 2020 US FDA Funding Increase

The agency requested a funding increase in part to implement 2018 legislation intended to combat the opioid crisis, but also to support many initiatives in last year's budget request.
FDA Legislation

Bill To Revise US Subject Matter Patent Eligibility Standard Expected By 'Early Summer'

Senators emphasize need for legislative reform at IP subcommittee hearing; ask USPTO director Iancu how a drug can have 130 patents, alluding to Humira.

Intellectual Property Legislation

CREATES Act: Republican Lawmakers Worry About Frivolous Lawsuits By Generic Firms

Association for Accessible Medicines' Davis tries to counter concerns that the long-stalled measure would incentivize lawsuits against brand companies; witnesses at a House subcommittee hearing on drug pricing legislation also testified that the BLOCKING Act would create an overly broad and complicated framework for triggering 180-day exclusivity.

Pricing Debate Generic Drugs
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