Expertise in all things FDA
Rep. Henry Waxman (D-CA), Sen. Charles Schumer (D-NY), and Sen. Hillary Rodham Clinton (D-NY) introduced the “Access to Life-Saving Medicines Act” last Friday. If enacted, the legislation would establish an abbreviated application approval pathway for biological products – so-called “generic biologics,” “follow-on …
John A. Gilbert will be the lead speaker for the Heathcare Distribution Management Association (HDMA) Webinar entitled Pseudoephedrine and Dextromethorphan Regulatory Review. This webinar will provide a regulatory review of all state and federal requirements for pseudoephedrine and dextromethorphan, an analysis of anticipated 2007 legislative and …
Getting CMS Reimbursement for Medical Products was presented at the FDLI/Clinical Device Group E-conference, September 7, 2006. FDA approved or cleared products are eligible for Medicare coverage and payment. However, many manufacturers have discovered that the Medicare coverage process, administered by the Centers for Medicare & …
On August 22, 2006, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register a proposed rule entitled “Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2007 and Other Changes to Payment Under Part B.” Although …
Hyman, Phelps & McNamara is sponsoring and Wes Siegner will give a presentation at the Second Annual Nutritional Law Symposium in Salt Lake City, Utah.
Coordination Between FDA And CMS: Strategic Considerations For Medicare Coverage And Payment, And The Growing Impact Of CMS In The Marketplace was presented at the FDA Regulatory and Compliance Symposium at Harvard, August 22-25, 2006. Medicare is the largest purchaser of health care in the U.S., …
In June 2006, the FDA issued its long-awaited Compliance Policy Guide (“CPG”) concerning the Agency’s enforcement priorities and policies for marketed unapproved drugs. FDA’s final CPG is part of FDA’s ongoing drug safety initiative.
On July 18, 2006, Medtronic, Inc. reached a settlement agreement with the U.S. Department of Justice pursuant to which Medtronic will pay $40 million to the United States and participating states to settle allegations stemming from two qui tam lawsuits, United States ex rel. [UNDER …
After much delay, the Centers for Medicare & Medicaid Services (CMS) issued its final policy on Coverage with Evidence Development (CED) on July 12, 2006. The policy revises the controversial draft policy, issued on April 7, 2005, in response to public comments that raised …
On July 10, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Analysis (NCA) tracking document to reconsider its Clinical Trial Policy (to be renamed Clinical Research Policy), originally issued in 2000. The reconsideration is open for public comment through August …
“Authorized generics” have increasingly been the subject of debate as brand-name firms more frequently incorporate them into lifecycle management strategies, often to dilute the effects of generic competition. The recently enacted Deficit Reduction Act of 2005 (DEFRA) may curb the marketing of some authorized generics …
Medical Device Regulation: Getting to the Market and Navigating the Regulatory Pitfalls, A symposium sponsored by Hyman, Phelps & McNamara, P.C. May 11, 2006 Hyatt Regency Irvine Irvine, CA
The Sixth Circuit in the case of Abney v. Amgen, Inc. has affirmed the district court’s denial of the plaintiffs’ request to order Amgen to continue to provide an investigational drug. The plaintiffs participated in a clinical trial of a drug to treat Parkinson’s …
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 …
March 17, 2005 marked the 25th anniversary of the date the firm opened its doors for business. To commemorate the occasion, HPM employees celebrated with a formal dinner and dance at the National Museum of Women in the Arts.
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 …
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 …