PRESS RELEASE: Pharma Regulatory and Pricing Updates; Sign Up for a Complimentary Inside Health Policy Trial

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WASHINGTON, DC USA -- PHARMA UPDATE NEWS SERVICE™ -- APRIL 23, 2019: Sign up for a free trial subscription to Inside Health Policy, the online news service on health care policy from the regulatory reporting experts at Inside Washington Publishers.

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Regulatory Experts: OMB Memo Could Drastically Slow FDA Guidances
Sources say a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress -- could throw a wrench in FDA's usual guidance-making process, which could negatively affect both the agency and industry.

FDA Rebuffs PhRMA, Weighs Off-Label Use In Deciding If REMS Needed
FDA will consider the extent to which a drug's intended population is expected to use the product for off-label uses when deciding whether to require a risk mitigation program for certain drugs, a policy the brand industry had alleged may exceed the agency's statutory authority. The decision is tucked into a final guidance issued Thursday (April 4) that lists six factors FDA will consider when weighing whether a Risk Evaluation and Mitigation Strategy (REMS) is needed to ensure a drug's benefits outweigh its risks when new safety information arises.

FDA Chief Counsel, DOJ Promise Off-Label Enforcement Based On Risk, Patient Harm
FDA Chief Counsel Becky Wood's recent remarks that FDA is taking a 'risk-based approach' toward warning letters, focusing on 'significant public health risks, rather than overly technical or insignificant violations,' left one industry attorney pleased, pharma critics frustrated and some policy watchers waiting for more details before predicting how the Trump FDA will deal with off-label promotion. Wood's remarks came just days after a deputy assistant attorney general also underscored that the Department of Justice will go after off-label cases that result in patient harm, rather than pursuing 'technical regulatory violations.'

Grassley: If No Drug-Pricing Deal By June, Likely Won't Happen This Year
Senate Finance Chair Chuck Grassley (R-IA) said Wednesday (April 10) if senators cannot reach consensus on a package to lower prescription drug costs by June, such a package may not pass this year. That gives Grassley around two months to negotiate a multi-committee proposal to lower health and drug costs with Finance ranking Democrat Ron Wyden (OR), health committee chair Sen. Lamar Alexander (R-TN), and health ranking Democrat Sen. Patty Murray (D-WA).

Ways & Means Unanimously Approves Drug-Pricing Transparency Bill
The House Ways & Means Committee on Tuesday (April 9) unanimously approved drug-pricing legislation that would demand price transparency from drug makers and pharmacy benefit managers. Though he voted for it, Rep. Lloyd Doggett (D-TX), who has been an outspoken advocate for lowering drug prices, criticized the measure for not going far enough.

Wyden: Rx Makers Refuse To Commit To Lower Prices If Rebates Banned
The night before drug-channel middlemen were set to testify before Senate Finance, the committee's ranking Democrat said drug companies refuse to commit to cutting drug prices if Congress eliminates drug rebates. HHS Secretary Alex Azar plans to either eliminate rebates in Medicare and Medicaid or force insurers to share them at the point of sale, and he wants Congress to follow suit in the commercial market.

Wyden Says Premium Demo Designed To Mask HHS' Bad Drug-Rebate Policy
CMS' planned premium risk-reduction demonstration is designed to mask HHS' bad drug-pricing policy, according to Sen. Ron Wyden (OR), the ranking Democrat on the Finance Committee. CMS on Friday (April 5) issued a guidance telling Part D plans that Medicare would cover nearly all of the cost of setting premiums too low in advance of a planned rule that is expected to lead to higher premiums by eliminating rebates.

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