Publications

On May 2, 2006, the United States Court of Appeals for the District of Columbia Circuit concluded in a two-to-one ruling that mentally competent, terminally ill adult patients have the right to obtain potentially life-saving investigational new drugs that FDA has determined, based on Phase …

Continuing Medical Education (CME) plays a critical role in the healthcare system. Medical school is merely the start of a physician’s education; however, physicians need to remain current in the decades following completion of their formal education. With the rapid growth in medical information, the …

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 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, …

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. …

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 …

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, …

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, …

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.

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, …

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 …

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 …

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 …

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 …

To review the pharmacology, safety, and efficacy of the prokinetic agents metoclopramide and erythromycin in children.

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 …

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 …

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 …

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 …

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 …

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).

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 …

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 …

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 …

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 …

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.