Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....
April 19 — The House Appropriations Committee April 19 approved a bill (bill number not available) that would increase funding for the FDA in fiscal year 2017.
The bill would give the Food and Drug Administration $2.7 billion in discretionary funding, an increase of $33 million over the FY 2016 enacted level. Total funding for the FDA, including revenue from industry-paid user fees, would be $4.78 billion, which would be $97.4 million above FY 2016. Within this total, medical product safety activities would increase by $9.4 million, and food safety activities would rise by $33.2 million.
The bill also provides $10 million in funding to the FDA “to combat Zika and Ebola outbreaks by helping to fund ongoing response activities, and to expedite the development and availability of medical products to fight the viruses,” a press release on the bill said.
Rep. Rita Lowey (D-N.Y.), ranking member of the committee, offered an amendment to the bill that would have provided $1.9 billion in supplemental funding to combat Zika, but that amendment was blocked. Committee Chairman Harold Rogers (R- Ky.) offered an amendment to Lowey's amendment that adds bill language to clarify that certain existing, unobligated funding within the departments of State and Health and Human Services shall be available to combat Zika. The amendment was adopted on a vote of 30-20.
The report accompanying the bill contains several FDA-related provisions on opioids, drug compounding, laboratory developed tests and medical device facility inspections.
The bill next goes to the House floor for consideration.
The appropriations bill also contains language that would restrict how the FDA implements a rule on generic drug labeling that has been criticized by industry.
The FDA issued the proposed rule in 2013 (11 PLIR 1369, 11/15/13). Under the rule (RIN-0910-AG94), generic drug manufacturers would be able to independently update product labeling, also called prescribing information or package inserts, with newly acquired safety information before the FDA's review of the change, in the same way brand drug manufacturers do. Generic manufacturers also would be required to inform the branded manufacturer about the change.
The FDA has said it plans to publish the final rule in July.
The appropriations bill states that none of the funds that it provides may be used by the FDA to implement the generic labeling rule, unless the final version of the rule requires that the agency:
The committee said in the report accompanying the bill that it supports providing incentives to clinicians for using abuse-deterrent formulations of opioids and increasing the number of prescribers who receive training on pain management and safe prescribing of opioid drugs.
The committee also said it supports efforts at the FDA and elsewhere to develop medication-assisted therapies (MATs) “that improve efficacy of daily administration, are resistant to diversion and misuse, and/or help patients on a path to abstinence.”
Additionally, the committee asked the FDA “to ensure that the administration of naloxone serves as a point of intervention to spur an honest conversation between the patient and his doctor about addiction and treatment.” Naloxone is a drug that treats overdoses.
On drug compounding, the committee said in the report that it is concerned that since the passage of the Drug Quality and Security Act (DQSA) of 2013 (Pub. L. No. 113-54), the FDA has interpreted the compounding provisions “in a manner inconsistent with its legislative intent and with the agency's own previous positions.”
The DQSA distinguishes between compounders engaged in the traditional pharmacy practice of making customized drugs for specific patient needs and those compounders making large volumes of compounded drugs without individual prescriptions. Compounders outside the scope of traditional pharmacy practice can voluntarily register with the FDA as “outsourcing facilities” and become subject to federal oversight like traditional drug manufacturers. Section 503A of the Federal Food, Drug, and Cosmetic Act, as amended by the DQSA, describes the requirements for traditional compounding pharmacies and Section 503B describes the requirements for outsourcing facilities.
The committee said the FDA has taken the position that under Section 503A, “a pharmacist may not compound medications prior to receipt of a prescription and transfer the drugs to a requesting physician or other authorized agent of the prescriber for administration to his or her patients without a patient-specific prescription accompanying the medication.”
“This practice, which is often referred to as ‘office-use' compounding, is authorized in the vast majority of states and was intended to be allowable under DQSA,” the report said.
The committee said it “directs the FDA to issue a guidance document on how compounding pharmacists can continue to engage in ‘office-use' compounding before the receipt of a patient-specific prescription consistent with the provisions of 503A within 90 days after the enactment of this Act.”
The committee said it “understands that the FDA is interpreting provisions of Section 503A of the FDCA to inspect state-licensed compounding pharmacies under current good manufacturing practices (cGMPs) instead of the standards contained in the United Sates Pharmacopeial Convention (USP) for sterile and non-sterile pharmaceutical compounding or other applicable pharmacy inspection standards adopted by state law or regulation.”
The committee said “compounding pharmacies are not drug manufacturers, but rather, are state licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within their states,” the report said. “Compounding pharmacies are more appropriately inspected using USP standards or other pharmacy inspection standards adopted by state law or regulation in the state in which a pharmacy is licensed.”
The committee also directed the FDA in the report to suspend further efforts to issue a final guidance governing laboratory developed tests (LDTs).
The committee said the FDA's draft guidance issued in 2014 on LDTs “puts forth a proposed regulatory framework that is a significant shift in the way LDTs are regulated” and “such a shift deserves input from the public.”
“The FDA's guidance circumvents the normal rulemaking process and changes expectations for patients, doctors, and laboratories for the first time” since the Clinical Laboratory Improvement Amendments was passed in 1988, the report said. The LDTs have been regulated by the Centers for Medicare & Medicaid Services under the CLIA law.
The committee directed the FDA to “continue working with Congress to pass legislation that addresses a new pathway for regulation of LDTs in a transparent manner.”
The committee also said in the report that it is “concerned about the lack of transparency and consistency with the medical device facility inspection process” and it urges the FDA “to work with stakeholders and Congress to improve” the process.
“Potential process improvements may include, but are not necessarily limited to, more timely and frequent communications related to inspection observations and remediation plans, as well as changes to the way medical device Export Certificates (e.g., Certificate to Foreign Government, etc.) are affected by FDA Observational Findings following a facility inspection,” the report said.
The report also said that the FDA “shall produce a report to the Committee by September 30, 2016, which provides information on the rates of inspection for facilities across districts and internationally and any FDA efforts to standardize rates of inspections.”
To contact the reporter on this story: Bronwyn Mixter in Washington at email@example.com
To contact the editor responsible for this story: Janey Cohen at firstname.lastname@example.org
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)