Publications

Federal Court Holds FDA to 180-day Statutory Deadline for Approving Drug Marketing ApplicationsApril 10th, 2006
On April 10, 2006, the United States District Court for the District of Columbia issued a memorandum opinion in the case of Sandoz, Inc. v. Leavitt that is useful precedent for companies with drug applications languishing at the FDA. In this case, the court granted …
The Drug Enforcement Administration’s Final Rule on Theft and Significant Loss Reporting: We Can See More Clearly NowApril 1st, 2006
The pharmacist in charge of Kilgoban Pharmacy is conducting a routine inventory. When comparing the actual on-hand quantity of schedule II drugs with a computergenerated printout of the theoretical count, the pharmacist finds that the oxycodone 40 mg. tablet counts do not match. In fact, …
Product liability drug case not preempted by FDC ActMarch 3rd, 2006
On March 3, 2006, Judge Crabb in the Western District of Wisconsin denied the defendants’ motion to dismiss. Plaintiff contends he lost his sense of taste after taking Prilosec. Judge Crabb ruled that plaintiff’s state common law claims are not preempted by FDA regulations. …
Medicare CED: Considerations and ImplicationsMarch 1st, 2006
In light of the rapid pace of development of new medical technology and treatment, the Centers for Medicare & Medicaid Services (CMS) is faced with a significant challenge in developing an efficient process to determine what technology and treatments effectively improve the health outcomes of …
Bioshield II: One Step Forward, One Step Back?March 1st, 2006
The Deficit Reduction Act of 2005: Amendments To The Medicaid Rebate Program and Drug PaymentFebruary 6th, 2006
It’s The Law: Disgorgement and RestitutionFebruary 1st, 2006
FDA Issues Long-Awaited Prescription Drug Labeling RegulationsJanuary 26th, 2006
On January 24, 2006, the FDA formally issued its long-awaited prescription drug labeling regulations, as well as draft and final guidance documents further describing the implementation of certain aspects of those regulations. FDA’s final regulations, which were issued as proposed regulations in December 2000, …
Responding to FDA Form 483 or FDA Warning LettersJanuary 18th, 2006
The Drug Enforcement Administration’s Final Rule on Theft and Significant Loss Reporting: We Can See More Clearly NowJanuary 1st, 2006
The pharmacist in charge of Kilgoban Pharmacy is conducting a routine inventory. When comparing the actual on-hand quantity of schedule II drugs with a computergenerated printout of the theoretical count, the pharmacist finds that the oxycodone 40 mg. tablet counts do not match. In fact, …
Clinical Trials Disclosure Requirements: Too Much of a Good Thing?January 1st, 2006
Qualified Health Claims: Creatures of Case LawNovember 15th, 2005
What You Don’t Know about AIP Can Hurt YouNovember 1st, 2005
The FDA wields a powerful tool called the Application Integrity Policy list. Device manufacturers need to be aware of this list and avoid being placed on it. Additional information available here.
Product Jurisdiction – New DevelopmentsOctober 12th, 2005
PRIMARY MODE OF ACTION FINAL RULE On August 25, 2005, FDA issued a final rule amending its combination product regulations to define “mode of action” and “primary mode of action” (PMOA) to be used in assigning a combination product to an agency component, i.e., CDER, CBER, …
Government Investigations: Responding to Requests for Information Including E-DiscoverySeptember 30th, 2005
FDA’s Unauthorized User Fee Money GrabAugust 12th, 2005
Condition of Approval Studies: FDA Takes A New LookAugust 1st, 2005
Medical device companies spend considerable time and resources conducting clinical studies to demonstrate the “reasonable assurance of safety and effectiveness” that is needed to gain approval from the Food and Drug Administration (FDA) of a premarket approval application (PMA). But when FDA’s Center for Devices and …
Just Sign on the Dotted Line?June 20th, 2005
Medical research studies with human subjects are essential to develop lifesaving drugs and medical devices. The medical community needs volunteers—both healthy individuals and those with the disease or condition being investigated—for such studies. The subject’s in- formed consent is key to ensuring that participation is …
Exploring other options, Part 2: Facilitating the FDA review processJune 1st, 2005
New Case Raises Doubts on FDA’s Authority to Obtain Restitution and DisgorgementMay 30th, 2005
In recent years, the Food and Drug Administration (FDA) has embarked on a campaign to add restitution and disgorgement – remedies aimed at correcting past conduct – to FDA’s enforcement armamentarium, notwithstanding the absence of any statutory authority to do so. FDA entered into several high-profile …
Further Protecting the Food SupplyMay 1st, 2005
Exploring other options, Part 1: The trend toward alternative market pathwaysMay 1st, 2005
Federal and State Requirements for HCT/Ps: An OverviewMay 1st, 2005
The Food and Drug Administration (FDA) is close to finalizing its program for the regulation of human cells, tissues, and cellular or tissue-based products (HCT/Ps). On May 25, 2005, the donor eligibility and current good tissue practice (CGTP) final rules take effect, putting into place …
Perspectives on FDA’s Ephedra Rule and the Court OrderApril 27th, 2005
FDA Issues Good Review Management Principles and Practices Guidance DocumentApril 22nd, 2005
FDA Draft Guidance on Exploratory IND StudiesApril 22nd, 2005
Prokinetic drug therapy in children: a review of current optionsApril 1st, 2005
To review the pharmacology, safety, and efficacy of the prokinetic agents metoclopramide and erythromycin in children.
FDA Must Reform Its Arbitrary Drug Name Review ProcessJanuary 28th, 2005
Expanding FDA’s Authority to Protect the Food Supply: Administrative DetentionJanuary 1st, 2005
FDA’s Right to Get Disgorgement Is ThreatenedJanuary 1st, 2005
In the last five years, FDA has entered into a number of high-profile settlements with companies that have agreed to disgorge (forfeit) profits from their sales of products that FDA believed violated the FDC Act. These actions followed a ruling by the Sixth Circuit that …
Courts Scrutinize FDANovember 4th, 2004
The Food and Drug Administration (“FDA”) has, in recent years, embarked on a campaign to add restitution and disgorgement – remedies aimed at correcting past conduct – to its enforcement armamentarium. Several high-profile court settlements with large drug and medical device manufacturers seemed to indicate …
Comparative Claims: Legally Permissible, But Proceed with CareSeptember 1st, 2004
Legally, medical device companies may promote their devices with claims of superiority over competing products-or over previous versions of the company’s own products. However, FDA scrutinizes such claims carefully. The agency views comparisons with suspicion, believing that they are potentially misleading and seldom complete. Over …
Current Good Manufacturing Practices, and FDA Enforcement Actions and InspectionsJuly 24th, 2004
Vermont AWP Disclosure and Drug Marketer Gift Reporting LawsJune 2nd, 2004
New Price Disclosure Law: In June 2004, Vermont enacted a drug price disclosure law which requires pharmaceutical companies doing business in Vermont to disclose the Average Wholesale Price (AWP) as reported to a nationally recognized drug pricing file, such as First DataBank, for the …
State Regulation of Pharmaceutical Clinical TrialsJanuary 1st, 2004
The Food and Drug Administration’s Actions on Ephedra and AndrostenedioneJanuary 1st, 2004
FDA’s Regulation of Combination Products: The Road AheadNovember 1st, 2003
The Food and Drug Administration (FDA) applies different regulatory requirements to products depending upon whether they are medical devices, drugs or biologics. The agency has established different centers to handle these different types of products: for drugs, the Center for Drug Evaluation and Research (CDER); for …
Close but No Cigar: The WHO Framework Convention on Tobacco Control’s Futile Ban on Tobacco AdvertisingOctober 1st, 2003
Christine P. Bump, Comment, Close but No Cigar: The WHO Framework Convention on Tobacco Control’s Futile Ban on Tobacco Advertising, 17 Emory Int’l Rev. 1251 (2003).
Enforcement and Litigation Conference: Actions Against CompetitorsSeptember 23rd, 2003
Avoid FDA Problems: Implementing a Corporate Compliance ProgramJune 5th, 2003
When All Else Fails: Understanding the Medical Devices Dispute Resolution PanelJune 1st, 2003
Nearly five years ago, Congress directed FDA to set up an advisory panel to help resolve scientific disputes between the agency and industry. The result was the Medical Devices Dispute Resolution Panel. Operating under FDA’s Medical Devices Advisory Committee, the panel helps resolve product-specific scientific …
HIPAA and Drug Company Interactions with Physicians – Beyond Clinical ResearchMay 30th, 2003
FDA’s Regulation of Analyte-Specific ReagentsFebruary 1st, 2003
One of the most confusing areas of FDA regulation surrounds the requirements governing analyte-specific reagents (ASRs). ASRs are raw materials and components used to develop laboratory assays. This article will provide a brief background on FDA’s regulation of ASRs, summarizing the key ASR requirements and …
Promoting Devices for Specific Indications Based Upon a General ClearanceFebruary 1st, 2003
Many medical devices receive 510(k) clearance from FDA for general indications but are labeled and promoted for more specific indications. Frequently, FDA asserts that such specific uses are not covered by the original clearance and require separate 510(k) clearance or even premarket application (PMA) approval. For …
Western States Medical Center: A Watershed Moment for FDA’s Regulation of Commercial SpeechJanuary 31st, 2003
Universal health coverage anchored in the right to healthJanuary 17th, 2003
European Commissioner for Develop-ment Andris Piebalgs recently pointed out the need for “updated and modernised [Millennium Development Goals], pro-viding decent living standards for all – a set of minimum floors below which no one should fall”.1 He added that “these ‘MDGs plus’ would provide the …
Ripe for Revision: Reassessing the Contitutionality of Food and Drug Administration Restriction on Protected SpeechJanuary 1st, 2003
Can FDA Seek Restitution or Disgorgement?January 1st, 2003
In the past few years, the FDA has obtained some very large settlements from companies under the novel legal theories of “restitution” and “disgorgement.” Although the Federal Food, Drug, and Cosmetic Act doesn’t explicitly provide for restitution or disgorgement, the FDA has argued that courts …
Medical Device Reporting: A Risk-Management ApproachJanuary 1st, 2003
Filing medical device reports (MDRs) is undesirable and presents a certain amount of risk to the manufacturer. Fortunately, this risk can be ameliorated by approaching event reporting mindfully and carefully. Most importantly, device makers must not underestimate the risk involved in choosing not to file.
Claims for Functional Foods Under the Current Food Regulatory SchemeSeptember 30th, 2002
Claims for Functional Foods Under the Current Food Regulatory Scheme (Nutrition Today, Functional Foods issue, Vol. 37, No. 5, pp. 217-219)