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Advocacy at a Glance

March 1, 2019

Hill Requests Are Due: Now Through Early April. This is the time of year when appropriations committee members (House and Senate) solicit input from other Members and stakeholders about programs that need better funding. The Alliance will be submitting comments to many of these Members and urges you to do so as well. This document contains a list of members of our authorizing and appropriations committees who have posted information on how to comment and deadlines for submissions. Some have forms, others just want a brief statement. We will keep this list updated with additional offices and changes (if any) in deadlines. Note that four of the offices have March 1 (today) deadlines. For more information, contact Roger Szemraj.

House Appropriations Subcommittee Holds FDA Status Hearing With Commissioner Gottlieb. The House Ag/FDA appropriations subcommittee held a hearing on February 26 on FDA’s Status of Operations following the shutdown. Commissioner Gottlieb’s remarks submitted for the record can be found here. A video of the hearing can be found here.

Commissioner Gottlieb said that inspection work is “back on track,” although FDA will not be able to inspect as many food and medical product facilities and imports this fiscal year. Policy work in various areas was slowed and will take time to catch up. Among other areas, he identified FDA’s plan to link claims data to EHRs in support of the Sentinel safety data base, planned activities dealing with cannabidiol products, expanding the FAERS adverse event reporting system, and numerous improvements to the drug submission and review process. Other topics raised by subcommittee members included: sesame as an allergen, increasing the availability of generics to help reduce drug prices, drug compounding, improving food safety operations in future shutdowns, modernizing the regulation of cosmetics, continuing concerns regarding alternatives to oxycontin, and more strenuous regulation of e-cigarettes.

Hill Requests: What Are We Asking For? The Alliance will not have a formal “ask” until sometime after the President’s Budget is released. (Our expectation is a skinny version the week of March 11; and a more detailed version the week of March 18.) As in years past, we find the President’s request to be an important data point in our deliberations about how much to ask from Congress. As a result, for those Members with deadlines that come sooner, we are submitting “placeholder” requests that reflects our general advocacy for sufficient funding for FDA to fulfill its critical public health mission. We will later update our requests with a specific “ask” number. The text of our placeholder request is in this week’s Analysis and Commentary, along with additional directions on how to submit and what you might choose to say.

Annual Alliance Lobby Day — Mark Your Calendars — March 19. On Tuesday, March 19, 2019, the Alliance will be on Capitol Hill for our Annual Lobby Day. On Lobby Day, we strive for the largest number of participants and meetings, so we can help educate Congress about the mission of FDA and the importance of it being well-funded. We want to see you there! If you can attend, RSVP and let us know your availability. Please direct your questions to Samantha Beard.

Alliance to Host FDA Deputy Commissioner for Policy on April 10. Alliance members and media are invited to our upcoming meeting with Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis at FDA. The event is on Wednesday, April 10 from 2:00 p.m. to 3:00 p.m. and will be at a convenient downtown DC location. Her remarks should provide valuable insight into FDA’s priorities for the rest of FY 19 and for FY 20. To attend, RSVP. We will provide follow up with more information. If you have questions, e-mail Samantha.

The FDA Shutdown as Experienced by FDA Employees. When Dr. Gottlieb testified this week on the impact of the shutdown on FDA, the National Treasury Employee Association submitted a statement to the House Ag/FDA Appropriations Subcommittee on the perspective of FDA employees. It can be read here.

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