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HHS Drug Pricing Disclosure Rule: Chance at a Renewed Life Following District Court Appeal?
August 26, 2019 | Blog | By Joanne Hawana
Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court. On August 21, 2019, the U.S. Department of Health and Human Services (HHS) filed a notice of appeal against a federal judge’s decision to block an HHS final rule that would require drugmakers to disclose product list prices within consumer-directed television advertisements for certain prescription drugs.
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Congress Looking to Streamline CBD Drug Research
August 14, 2019 | Blog
Recently, a bipartisan group of Senators introduced the Cannabidiol and Marijuana Research Expansion Act (S. 2032), a bill to encourage scientific and medical research on marijuana and its compounds including cannabidiol, or CBD. The bill would expedite the process by which researchers can request an increase in the amount of a Schedule I substance used for approved research by sidestepping the FDA when requesting more marijuana for use in their research. The legislation also would streamline development of FDA-approved drugs that use CBD and marijuana by allowing accredited medical and osteopathic schools, practitioners, research institutions and manufacturers with a Schedule I registration to manufacture marijuana for research.
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In Policy Reversal, HHS and FDA Propose Plan to Import Foreign Drugs
August 8, 2019 | Blog | By Benjamin Zegarelli
On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published a proposal, called the Safe Importation Action Plan, to allow certain entities to import drugs from foreign entities. While this development was not a surprise given President Trump’s campaign promises to lower drug prices by, among other things, removing barriers to drug product importation, it represents a stark departure from prior agency positions that the importation of drugs could not be adequately verified as safe and would not lead to significant cost reductions.
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Three Things to Learn from Delaware Supreme Court’s Opinion on Board of Director Oversight Duties (Marchand v. Barnhill)
August 6, 2019 | Blog
In June 2019, the Delaware Supreme Court issued a decision reaffirming a risk of director liability where there is no board-level reporting process for essential compliance matters. The facts of the case arise from a 2015 listeria outbreak at Blue Bell manufacturing which resulted in the death of three people. The Delaware case reaffirmed the position that directors may be subject to liability if the director “(1) completely fail[ed] to implement any reporting or information system or controls, or (2) having implemented such a system or controls, consciously fail[ed] to monitor or oversee its operations thus disabling themselves from being informed of risks or problems requiring their attention.”
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FDA Invites Compounding Outsourcing Facilities' Comments to Understand Industry Challenges and Opportunities
July 29, 2019 | Blog
On July 29, 2019, the Food and Drug Administration (FDA) published a notice to the Federal Register (84 Fed. Reg. 36609). The notice invites comments on information collected in connection with FDA research by obtaining information from pharmacists and other management at outsourcing facilities as well as related compounding businesses. The collected information will support a comprehensive analysis of the outsourcing facility sector with hopes to inform future FDA work in this area.
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Software Update: The Latest on FDA’s Pre-Cert Pilot
July 22, 2019 | Blog
Regular readers of this blog know that we’re closely following the FDA’s proposed regulatory framework for software as a medical device (SaMD), known as precertification—Pre-Cert for short. Generally, Pre-Cert involves a premarket evaluation of a software developer’s culture of quality and organizational excellence and continual, real-time postmarket analyses to assure software meets the statutory standard of reasonable assurance of safety and effectiveness.
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Federal Judge Strikes Down HHS Drug Pricing Disclosure Rule
July 9, 2019 | Blog
In follow-up to our previous post, the pharmaceutical industry gained a win on July 8th when a federal judge struck down the Trump administration’s rule that would have required drugmakers to include list prices for drugs in TV ads.
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Pharmaceutical Companies Object to HHS Drug Pricing Disclosure Rule
July 1, 2019 | Blog | By Joanne Hawana
Several parties from the pharmaceutical industry have teamed up with an advertising association to file a lawsuit against the Department of Health and Human Services (HHS) to prevent a new drug pricing disclosure rule from going into effect. The legal challenge was filed on June 14, 2019 and takes issue with a final rule adopted by HHS on May 8, 2019 (which we previously blogged about here) that purports to provide consumers with information regarding the price of prescription drugs. However, opponents to the HHS rule counter that the opposite will occur and that it will actually mislead patients about the price of prescription drugs. This point may not be difficult for the plaintiffs to demonstrate in support of their request for a declaratory judgment that the rule is unlawful, since even HHS has admitted in the final rule preamble that the new requirement may “discourage patients from using beneficial medications, reduce access, and potentially increase total cost of care.”
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OIG Report Finds a Small Percentage of Hospitals Do Not Obtain Compounded Drugs from FDA-Registered Outsourcing Facilities
June 17, 2019 | Blog | By Joanne Hawana
On June 6, 2019, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a report that found among a sample U.S. hospitals that obtained non-patient-specific (NPS) compounded drugs from outside compounders, 89% of hospitals obtained them only from compounders that were registered with the U.S. Food and Drug Administration (FDA) as outsourcing facilities. The OIG study was conducted to provide the FDA with insights to improve its oversight of compounders and enhance patient safety. According to the study, “factors associated with quality, including registration with FDA as an outsourcing facility, are among the most important factors considered when hospitals decide where to obtain their non-patient-specific compounded drugs.” Although use of compounded drugs is widespread in hospitals, the OIG also found that it is rare for hospitals to consider registering their own pharmacies as outsourcing facilities.
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Navigating the Legalization of Hemp under the 2018 Farm Bill Involves Changes to the Issuance of Federal Trademarks in the Cannabis Industry
June 11, 2019 | Blog | By Susan Neuberger Weller
Legalizing “hemp” under the Agricultural Improvement Act of 2018 (2018 Farm Bill) has triggered an important change for the examination of federal trademark applications concerning cannabis and cannabis-derived goods and services. In response to the Bill’s enactment on December 20, 2018, the United States Patent and Trademark Office (USPTO) issued a new examination guide to clarify its examination procedures involving hemp goods and services. For businesses in the cannabis industry, the examination guide (recently issued on May 2, 2019) will impact the viability of federal trademark applications filed on or after December 20, 2018 that were once previously barred.
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Cannabis-Derived Ingredients in FDA-Regulated Products: More Questions than Answers at FDA’s May 2019 Public Hearing
June 3, 2019 | Blog | By Joanne Hawana
As most folks with any interest in the burgeoning cannabidiol (CBD) industry likely know, on May 31, 2019, the Food and Drug Administration held a public hearing “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” Stakeholders who attended the hearing presented many diverse viewpoints and the FDA panelists – who were in listening mode – received extensive information from across that spectrum of perspective.
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FDA Ratchets Up Pressure on Homeopathic Drug Manufacturers
May 23, 2019 | Blog | By Benjamin Zegarelli
On May 14, FDA announced that it issued five Warning Letters to companies that manufacture and market homeopathic drugs for human use. The letters all cite cGMP deficiencies relating to inspectional observations and conclude that the products are misbranded prescription drugs under the Federal Food, Drug, and Cosmetic Act because “in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs” and they are not labeled for prescription use only.
In 2019 so far, FDA has issued Warning Letters to eleven separate homeopathic drug manufacturers, including the five letters referenced above. All of the Warning Letters, except one, cite observations from inspections and focus on cGMP and quality violations at the manufacturing facilities, including contamination and varying amounts of active ingredients, that could lead to consumer harm.
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In 2019 so far, FDA has issued Warning Letters to eleven separate homeopathic drug manufacturers, including the five letters referenced above. All of the Warning Letters, except one, cite observations from inspections and focus on cGMP and quality violations at the manufacturing facilities, including contamination and varying amounts of active ingredients, that could lead to consumer harm.
FDA Finalizes Guidance on Biosimilar Interchangeability, Reiterates Case-by-Case Approach to Data Requirements
May 16, 2019 | Blog | By Joanne Hawana
On May 10, 2019, the Food and Drug Administration issued highly anticipated final guidance that gives drug-makers more clarity on how to demonstrate that a proposed biosimilar product meets the statutory interchangeability standard under the Public Health Service Act (PHS Act or the Act). According to the Act, an interchangeable biosimilar may be substituted for the original biological product without the involvement of a prescriber, similar to the way generic drugs are routinely substituted for brand name drugs at the pharmacy level. The Final Guidance, entitled “Considerations in Demonstrating Interchangeability with a Reference Product,” is shorter than the draft version released over two years ago, in response to industry feedback, but generally tracks the original policy positions proposed in the draft, with a few notable exceptions summarized below.
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Update on FDA’s Comprehensive Regenerative Medicine Policies and Enforcement Activities
April 29, 2019 | Blog | By Joanne Hawana
FDA's Comprehensive Regenerative Medicine Policy Framework is nearing the halfway mark of the “grace period” the Agency extended for certain regenerative medicine product developers to come into compliance by obtaining investigational new drug applications (INDs) and working towards premarket approval of their products.
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FDA and Outgoing Commissioner Scott Gottlieb Open Up About Cannabis and CBD Regulation
April 23, 2019 | Blog
As predicted by our colleagues earlier this month, outgoing Commissioner Scott Gottlieb of the U.S. Food and Drug Administration (FDA) released a comprehensive press release setting forth actions for possible FDA regulation of CBD products. FDA also reinforced its position that introducing CBD or THC infused products into interstate commerce, including marketing CBD and THC dietary supplements, continues to be illegal. In furtherance of this position, FDA released three warning letters to businesses marketing CBD products for using “egregious and unfounded claims aimed at vulnerable populations.”
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FDA Silent on CBD Regulation at Cosmetics Conference, But Legislation May Be Imminent
April 1, 2019 | Blog | By Benjamin Zegarelli
Regulation of cannabidiol (CBD) was a hot topic on Day 1 of ACI’s Cosmetics & Personal Care Products conference on March 28, 2019. Attendees asked many questions about legitimate uses of and claims for CBD, but definite answers were in short supply due to the current confusion over the legality of CBD as a product itself or other products, such as food or cosmetics, with CBD added.
When asked a direct question about FDA’s perspective on and plans for CBD regulation, Dr. Linda Katz, Director of FDA’s Office of Cosmetics and Colors and Acting Chief Medical Officer for Food Safety and Applied Nutrition, did not comment directly but referred all attendees to an upcoming public meeting on CBD in April 2019. It is possible that the public meeting could be the start of an FDA rulemaking process for CBD regulations. Even though Dr. Katz was unable to comment, there was still plenty of CDB advice to share with industry attendees.
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When asked a direct question about FDA’s perspective on and plans for CBD regulation, Dr. Linda Katz, Director of FDA’s Office of Cosmetics and Colors and Acting Chief Medical Officer for Food Safety and Applied Nutrition, did not comment directly but referred all attendees to an upcoming public meeting on CBD in April 2019. It is possible that the public meeting could be the start of an FDA rulemaking process for CBD regulations. Even though Dr. Katz was unable to comment, there was still plenty of CDB advice to share with industry attendees.
Device Modernization Series: In Vitro Clinical Tests
March 7, 2019 | Blog
In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory developed tests (LDTs) and other in vitro diagnostics (IVDs). The proposed approach would create an entirely new category of medical product separate from medical devices known as in vitro clinical tests (IVCTs).
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What to Expect at FDA Following Commissioner Gottlieb's Departure
March 6, 2019 | Blog
On March 5, 2019, FDA Commissioner Scott Gottlieb announced his resignation. The physician and venture capitalist, for whom this was a second stint at the FDA, intends to leave the agency in about a month to spend more time with his family. In this post, Aaron Josephson reflects on Dr. Gottlieb's time leading the FDA and its future after his departure.
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Device Modernization Series: FDA’s Proposed De Novo Regulation
February 28, 2019 | Blog
In our first Device Modernization series post, we discussed how FDA is proposing to modernize the 510(k) review program. FDA also recently issued a proposed regulation for the De Novo program and linked that proposed regulation to 510(k) modernization efforts as part of a broader strategy to improve device safety.
The proposed De Novo regulation, issued December 5, 2018, would codify into regulation many of the policy and programmatic features of the De Novo program that are currently outlined in guidance documents. Because guidance is nonbinding, FDA is seeking through the proposed regulation to provide structure, clarity, and transparency to the De Novo process in a way that would be binding on De Novo submitters.
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The proposed De Novo regulation, issued December 5, 2018, would codify into regulation many of the policy and programmatic features of the De Novo program that are currently outlined in guidance documents. Because guidance is nonbinding, FDA is seeking through the proposed regulation to provide structure, clarity, and transparency to the De Novo process in a way that would be binding on De Novo submitters.
Hefty Fine is a Reminder of FCC’s Purview Over Certain Personal Hygiene and Wellness Devices
February 27, 2019 | Blog
Do you manufacture, import, or market personal hygiene and wellness devices sold in drugstores? If so, you may be focused on U.S. Food and Drug Administration (FDA) compliance, but may not have considered the requirements of another Federal regulatory agency: the Federal Communications Commission (FCC). Manufacturing, importing, and/or marketing non-compliant personal hygiene, wellness and similar devices may violate the FCC’s rules.
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