The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. The guidance finalizes an April 2019 draft that advised how firms in a distribution chain can prepare when conducting a voluntary recall. The guidance includes nonbinding recommendations and explicitly does not establish legally enforceable … Continue Reading
On December 23, 2019, the U.S. Food and Drug Administration (FDA) published in the Federal Register a set of proposed rules covering the requirements and procedures for importing under Section 804 of the federal Food, Drug, and Cosmetic Act (FDCA) prescription drugs from Canada. It is these proposed rules under which prescription drugs intended for … Continue Reading
The Office of the Inspector General (OIG) published a report in September 2018 after a review of the Food and Drug Administration’s (FDA) policies, procedures, and guidance relating to cybersecurity reviews of networked medical1 devices. In its findings, covered in our recent client alert, the OIG determined that while the FDA has started to include … Continue Reading
Last month, New Jersey joined several other states in adopting a new regulation limiting payments and gifts that can be made by pharmaceutical manufacturers to health care providers. The regulation caps include a maximum of $10,000 per calendar year for a prescriber’s bona fide services, and $15 per meal. Additional information about this new regulation … Continue Reading
Washington D.C. Partner Kevin Madagan of Reed Smith’s Life Science Health Industry group will participate in an exert legal panel discussion at the 2017 Health Care Distribution Alliance (HDA) Traceability Seminar held November 8-10 in Washington D.C. Implementation of the Drug Supply Chain Security Act (DSCSA) continues to transform the pharmaceutical supply chain. As the … Continue Reading
On October 25, 2017, FDA released a critical draft guidance on the breakthrough medical device pathway established by the 21st Century Cures Act (the “Cures Act”). The Draft Guidance For Industry, Breakthrough Device Pathway (“Draft Guidance”) reflects FDA’s proposal regarding the process by which a sponsor may seek a designation as a breakthrough device, assigning … Continue Reading
The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (“DSCSA”). The DSCSA establishes product tracing, licensure, reporting, and other requirements for certain trading partners … Continue Reading
On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs). According to FDA, the updated proposal is the result of ongoing engagement with industry stakeholders. Under the proposal, the FDA generally stands by its position that a complementary risk-based … Continue Reading
On December 29, 2016, the U.S. Food and Drug Administration (“FDA”) surprised many in the radiopharmacy industry by issuing a long-awaited draft guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies.” The guidance addresses conditions under which the FDA does not intend to take action for violations of 505, 502(f)(1) and 501(a)(2)(B) of … Continue Reading
FDA intends to issue long-awaited proposed regulations governing the licensing of prescription drug wholesale distributors and third-party logistics providers (“3PLs”) this December, according to the updated 2016 HHS regulatory agenda. Under the Drug Supply Chain Security Act (“DSCSA”), FDA was required to issue these regulations no later than two years following the law’s November 2013 … Continue Reading
The U.S. Food and Drug Administration (FDA) has approved more than 80 medical devices that involve 3D printing and one prescription drug. It also held a public workshop to obtain information and input about 3D printing issues on October 8 and 9, 2014. FDA brought together technical 3D printing expertise from various industries and sectors … Continue Reading
The increasing popularity of 3D printing is changing the future of health care far more dramatically than we would have ever imagined. Although we have blogged about 3D printing, and the Reed Smith white paper, “3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles” addressed regulatory issues for medical devices and … Continue Reading
On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for approving innovative drugs and medical devices, and to address other issues, including those regarding clinical trial design, research funding, and … Continue Reading
Upcoming changes to Google AdWords’ ad formats will have a significant impact on pharmaceutical companies that engage in paid search advertising. In a letter to its major media agencies last month, Google announced that it will be removing two of its popular pharmaceutical advertising units. Black Box Ad Format On July 20, 2015, Google’s Black … Continue Reading
FDA's Office of Prescription Drug Promotion has warned a Swiss drug company about failing to include risk information and omitting material facts regarding its products. What makes these particular violations noteworthy is that they occurred on the company's Facebook page. FDA became aware of the company's Facebook promotion through its own monitoring and surveillance program.… Continue Reading
On October 19, 2011 the Food and Drug Administration ("FDA") published a proposed rule in the Federal Register that would amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act (the "Proposed Rule"). Comments to the Proposed Rule should be submitted no later than January 17, 2012. This client alert summarizes these proposed changes and discusses the potential impact of the Proposed Rule on the drug, biological product, and biotechnology industry.… Continue Reading
On July 14, 2011, the Food and Drug Administration ("FDA") proposed to permit wholesale distributors to document the chain of custody (also known as a drug "pedigree") of prescription drug products only back to the last authorized distributor of record ("ADR"), instead of all the way back to the manufacturer. As explained in our client alert, FDA's proposal (if implemented) will not impact the current operations of wholesale drug distributors, and it does absolutely nothing to address a more pressing problem facing the industry - an increasingly complex patchwork of diverse state pedigree requirements.… Continue Reading
This post was also written by Robert J. Hill and Jennifer A. Goldstein. In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). In this analysis, … Continue Reading
On May 11, 2010, the U.S. Food and Drug Administration (FDA) launched a new initiative - the "Bad Ad Program" - designed to educate health care practitioners about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading. With the launch of this program, FDA, through the Division of Drug Marketing, Advertising, and Communications (DDMAC), a division within FDA's Center for Drug Evaluation and Research, is now actively seeking to "collaborate with health care professionals" to increase the effectiveness of the agency's marketing and advertising surveillance program. DDMAC is responsible for assuring prescription drug information is truthful, balanced, and accurately communicated, and guarding against false and misleading advertising and promotion through comprehensive surveillance, enforcement, and educational programs.… Continue Reading
FDA has released a proposed rule that would amend the regulations affecting direct-to-consumer ("DTC") advertisement regulations to implement a provision of the Food and Drug Administration Amendments Act of 2007. The change in regulations would require DTC television or broadcast advertisements of prescription drugs to place the "major statement" in a "clear, conspicuous and neutral manner." Under the regulation, FDA would use the following standards to determine whether the information meetings the clear, conspicuous and neutral requirement: 1) information is presented in language that is readily understandable by consumers; 2) audio information is understandable in terms of the volume, articulation, and pacing used; 3) textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and 4) the advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.
To learn more about FDA's proposed rule on DTC advertising, please read our full alert.… Continue Reading
Following a decade-long hiatus, the Food and Drug Administration ("FDA") appears ready to finally address industry Internet communications. FDA's Center for Drug Evaluation and Research ("CDER") in collaboration with other divisions within FDA, held a two day hearing on November 12th and 13th to help the Agency determine how the statutory provisions, regulations, and policies governing advertising and promotional labeling should be applied to product-related information on the Internet and emerging technologies...… Continue Reading
After just passing her eighth week as FDA Commissioner, Dr. Margaret Hamburg announced on August 6, 2009, six new enforcement procedures to a group of industry representatives, attorneys, consumers, and others attending a speech sponsored by the Food and Drug Law Institute in Washington, D.C.
"The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible," according to Commissioner Hamburg. She stated that vigilance means regular inspections and follow-up to ensure problems are resolved; identifying and resolving problems early; a "greater emphasis on significant risk and violations;" rapidly responding to egregious violations or violations that jeopardize public health; and using "meaningful penalties to send a strong message" to discourage future offenses. The Commissioner also said that the agency must be visible publicize its enforcement actions (and the rationale for those actions) widely and effectively. Commissioner Hamburg described six new policy changes to meet these goals.… Continue Reading
Numerous signals by the Food and Drug Administration ("FDA") in recent weeks, including statements made by Dr. Margaret A. Hamburg, the recently appointed FDA Commissioner, show that the agency intends to toughen enforcement in several areas. These signals should be taken seriously. An "awakened" FDA will be funded with additional monies promised for FDA's budget and with funding proposed through legislation such as The Drug and Device Accountability Act of 2009 (S. 882). As a result, firms that manufacture, import, and distribute FDA-regulated products can anticipate being visited more often, and probably more critically, than in the past. This, in turn, will force a company to handle additional Inspectional Observations (FDA 483s), Warning Letters, and reinforcement actions.… Continue Reading
On May 27, 2009, the Food and Drug Administration ("FDA") announced the availability of a draft guidance titled "Presenting Risk Information in Prescription Drug and Medical Device Promotion" ("Draft Guidance"). The Draft Guidance sets forth the standards FDA intends to consider when evaluating promotional pieces to determine whether they effectively communicate risk information in a non-misleading manner. Under the Food, Drug & Cosmetic Act ("FDCA") and FDA's implementing regulations, promotional materials making claims about a product are deemed misleading if they fail to disclose certain information about the product's risks. FDA is accepting comments on the draft through Aug. 25, 2009. Reed Smith's full alert provides a brief outline of the Draft Guidance and identifies issues for possible comment to FDA.… Continue Reading
