Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
The Food and Drug Administration's responsibilities continue to “outstrip” available resources, FDA Commissioner Margaret A. Hamburg said April 23 at the annual conference of the Food and Drug Law Institute.
“Having adequate resources remains a constant concern,” she said.
Hamburg said the agency will lose $209 million this year due to sequestration. Under sequestration, industry user fees also will remain in the Treasury and cannot be used, she said.
Additionally, she said the majority of FDA's budget increase in President Obama's budget request for fiscal year 2014 comes mostly from “enhanced” industry user fees.
The Obama administration's FY 2014 budget proposal, released April 10, seeks $2.6 billion in budget authority and $4.7 billion in total program resources for FDA (70 HCDR, 4/11/13).
The overall FY 2014 request is $821 million, or 21 percent, above the 2012 enacted level, according to the budget proposal. Of the $821 million increase, only $52 million is from budget authority. Industry user fees would fund 94 percent of the proposed budget increase.
Hamburg said the Food and Drug Administration Safety and Innovation Act (FDASIA) gave FDA new responsibilities, which, among others, require the agency to speed medical product reviews and reduce drug shortages.
Under FDASIA, FDA also is required to consider patient views on treatments, Hamburg said.
She said FDA is launching a patient network website that is meant to encourage patients to share ideas.
FDA also “has nearly completed an implementation plan” for FDASIA and “you can look for that in the near future,” Hamburg said.
Hamburg said the agency has seen some quality lapses in recent years that have caused drug shortages. “Drug shortages have increased fivefold since 2006,” she said.
Hamburg said quality is a major concern for the agency, and quality depends on the companies that manufacture drugs and devices.
“Quality has to be built into products,” she said. “Quality that's built into a product prevents problems.”
Hamburg said, “We've made progress in correcting and heading off drug shortages.” She noted, however, that quality issues continue.
Quality issues also caused the recent fungal meningitis outbreak that is linked to 53 deaths, Hamburg said. The outbreak was caused by contaminated drugs produced by a compounding pharmacy.
“This terrible tragedy must be a wake-up call to our nation,” she said.
Hamburg said FDA recently completed a series of inspections of compounding pharmacies and in some facilities found sterility problems and other issues that could cause contamination. For instance, Hamburg said inspectors found that some technicians were handling sterile products with their bare hands.
FDA inspectors “ran into resistance” from some compounding pharmacies, Hamburg said. “These obstacles are not new, and this is why I've asked Congress for additional authorities.”
Under these new authorities, nontraditional compounding would be subject to federal standards, Hamburg said. Traditional compounding pharmacies typically produce a small amount of custom-made medications for consumers who have a prescription. Nontraditional ones manufacture without prescriptions large quantities of drugs that are sometimes shipped over state lines.
Hamburg said under the new authorities, nontraditional compounding pharmacies would be required to report adverse reactions to FDA, and the agency would have clear authority to examine their records.
Hamburg said FDA's current authorities over compounding pharmacies “are limited and lack clarity.”
“New legislation is needed to address safety concerns and to provide a more tailored approach for compounding,” she said.
By Bronwyn Mixter
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)