BakerHostetler FDA and Pharmacy Weekly Digest - February 19, 2019

Alerts / February 19, 2019
Food/Dietary Supplements

FDA Releases Findings in Romaine Lettuce E. Coli Outbreak – The FDA announced the findings of its ongoing investigation into the E. coli outbreak from romaine lettuce originating in California. The FDA stated, “In the case of the one farm with a positive sample previously referenced, the FDA believes that the most likely way romaine lettuce on a specific ranch on this farm became contaminated was from the use of water from this reservoir as agricultural water. It is believed that this water came into contact with the harvested portion of the romaine lettuce, since the outbreak strain of E. coli O157:H7 was found in sediment from the reservoir and in no other sampled locations."


FDA Promotes Innovation in Drug Manufacturing – Commissioner Gottlieb announced the FDA’s recognition of certain voluntary consensus standards focused on drug quality in the manufacturing process. The FDA simultaneously issued a draft guidance titled “CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.” The guidance introduces a program to develop product quality standards. The guidance will allow for industry, stakeholders and FDA staff to provide input during development of the program.

FDA Issues New Policy Focused on Drug Access and Price Competition – The FDA announced a new policy to increase drug competition with respect to generics. The FDA stated its recognition that many branded drugs that are no longer covered by patents do not have generic coemption. The FDA’s new policy aims to support approvals of generic products for these types of products. Commissioner Gottlieb stated, “We’re working to reduce barriers to generic development and to lower the cost of generic entry so that more of the generic medicines that the FDA approves are launched and reach patients. Over the next year, the FDA will advance additional policies to promote generic competition including for complex drugs.” The FDA also issued a draft guidance titled “Competitive Generic Therapies” aimed at addressing inadequate generic competition.

Medical Devices

FDA Releases Device Establishment Inspection Guidance – The FDA published a draft guidance titled “Nonbinding Feedback After Certain FDA Inspections of Device.” The guidance outlines “how the owner, operator, or agent in charge of a device establishment may submit a request for nonbinding feedback to the FDA regarding actions the firm has proposed to take to address certain kinds of inspectional observations that have been documented on an FDA Inspectional Observations Form (Form FDA 483) and issued to the firm upon completion of an inspection of the firm’s establishment.”

FDA Authorizes Individualized Diabetes Management Devices – The FDA authorized the first interoperable insulin pump. The FDA stated, “This new type of insulin pump, referred to as an alternate controller enabled (ACE) infusion pump, or ACE insulin pump, is the first interoperable pump, meaning it can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual device preferences.”

FDA Issues Two Guidance Documents Related to Regenerative Medicine – The FDA published a final guidance titled “Evaluation of Devices Used With Regenerative Medicine Advanced Therapies” and another titled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.” The first addresses how the FDA plans to evaluate proposed devices “used in the recovery, isolation, or delivery of regenerative medicine advanced therapies.” The second focuses on expedited development of those regenerative medicines to treat serious and life-threatening diseases or conditions.

FDA Warns Doctor Promoting Unapproved Product to Treat Breast Implant Scar Tissue – The FDA issued a statement about a California doctor improperly marketing an unapproved medical device claiming to prevent and treat scar tissue associated with breast implants. In conjunction, the FDA issued a warning letter to the doctor for such actions – citing deviations in the quality system requirements and current good manufacturing practices.


FDA Finalizes Compounding Rule – The FDA announced the finalized rule setting out six bulk drug substances that can be compounded and four that cannot be compounded by facilities operating under Section 503A of the Federal Food, Drug and Cosmetic Act (FFDCA). This final rule does not apply to outsourcing facilities operating pursuant to Section 503B of the FFDCA.

House Holds Drug Pricing Hearing – On Feb. 12, 2019, the House Ways and Means Committee held a hearing on the cost of rising prescription drug prices. The hearing was part of the committee’s ongoing investigation into rising prescription drug prices. In his opening statement, Chairman Richard Neal acknowledged that “[t]he problem is complex, and Congress will need a multi-pronged approach to address it: we will need to change policies and incentives in the FDA, CMS, and potentially even look in the tax code. We need to change incentives within the system, and at the heart of this is the patient who needs relief.” Witness testimony is now available.

FDA Focuses Efforts on Opioid Crisis – The FDA announced its plans to target the illegal spread of opioids being distributed by international mail facilities (IMFs). Commissioner Gottlieb stated, “Tens of millions of packages are estimated to contain FDA-regulated products, and a surprisingly high percentage of these products are illegal. In fact, in recent years, 86 percent of the packages that were suspected of containing FDA-regulated products and were pulled for FDA review indeed contained illegal, illicit, unapproved, counterfeit and/or potentially dangerous drugs.” The FDA plans to increase enforcement related to these products. It is also increasing staffing to work with U.S. Customs and Border Patrol to more closely monitor products entering the U.S. from IMFs.

Senate Introduces the Stop Price Gouging Act – Democrats in the Senate introduced a bill to combat rising drug prices through an excise tax. For an in-depth summary of the bill, visit BakerHostetler’s Ohio Clock.

Authorship Credit: Lindsay P. Holmes

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