Dena Kessler

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First Amendment Right to Off-Label Promotion – Has Pandora’s Box Been Opened for FDA?

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products. Following on the heels of the Amarin case, another drug maker recently filed a lawsuit that may be the first of … Continue Reading

340B Guidance: Eight Key Points Covered Entities Should Consider

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush, Dena Kessler, Nita Garg and Lindsay Holmes on Posted in Uncategorized
On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to as “proposed” guidance by HRSA, the Guidance is intended to clarify a multitude of issues for the thousands of registered covered … Continue Reading

FDA Investigates Children’s Cough and Cold Medication With Codeine Amid Safety Concerns

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
In the wake of the European Medicines Agency’s (EMA) recently announced warning against giving codeine to children under 12 years old, the FDA announced its own safety investigation of the drug for use in children. The FDA’s renewed interest in pediatric codeine use comes two years after the agency issued a black box warning, its … Continue Reading

Proposed 340B Rule Would Impose Penalties for Overcharging, Plus Other Charges

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
A recently-released proposed rule would impose civil monetary penalties on drug manufacturers that intentionally overcharge healthcare providers for medications purchased under the 340B Discount Drug Program. The proposed rule, if adopted, could open the door to significant financial penalties for manufacturers, even if it is the manufacturer’s wholesaler or other business partner that overcharges the … Continue Reading

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care Management Association’s (PCMA) opposition to the legislation is not about the content of the bill but rather how Congress intends to pay for it. The 21st … Continue Reading

FDA Committee to Continue Considering Drug Compounding Issues

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
The advisory committee tasked with providing advice on medical, scientific and technical issues to the Food and Drug Administration (FDA) on compounded drugs is slated to continue its examination of matters concerning access to investigational new drugs and what components can be used in compounded products, among other topics. The FDA’s Pharmacy Compounding Advisory Committee … Continue Reading

FDA Finalizes Guidance Documents on Biosimilars

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush, Nita Garg, Dena Kessler and Lindsay Holmes on Posted in Uncategorized
Six years after legislation was adopted creating a new pathway for the approval of biological products that are biosimilar to existing FDA-approved biologics, the Food and Drug Administration (FDA) continues to issue guidance to clarify its interpretation of the law. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated licensure … Continue Reading

Compounding Pharmacies Protected by Medical Liability Act

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
In a court decision holding that a compounding pharmacy is entitled to certain protections against medical malpractice claims, the Supreme Court of Texas established a precedent that may well prove valuable to pharmacists facing lawsuits stemming from compounded drugs. The court ruled that claims brought by a patient who allegedly suffered serious injuries as a … Continue Reading

Latest Spike in Prescription Drug Spending Prompts OIG Investigation

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush, Lindsay Holmes and Dena Kessler on Posted in Uncategorized
A new report released by the IMS Institute for Healthcare Informatics shows that U.S. spending on pharmaceuticals increased in 2014 by 13.1 percent, reaching $373.9 billion. This is the highest increase since 2001 when drug spending growth reached 17 percent. According to the report, the most significant driver of medication spending was not the newly-insured … Continue Reading

CMS Fines Insurer for Misleading Medicare Part D Beneficiaries

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
The federal agency that oversees Medicare’s prescription drug program has alleged that a major U.S. insurance company misled beneficiaries about the pharmacies included in the company’s drug plan, and imposed a $1 million fine. According to a civil monetary notice issued by the Centers for Medicare and Medicaid Services (CMS), Aetna Inc. improperly reported that … Continue Reading

OMB Reviewing HRSA Proposed Rule For Civil Monetary Penalties And Ceiling Price Regulations For 340B Drug Discount Program

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would use civil monetary penalties to enforce ceiling price regulations. The Rule, proposed by the Health Resources and Services Administration (HRSA), rule seeks to enforce the … Continue Reading

Bringing Predictability and Speed to DEA’s Scheduling of New Drugs

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
A bipartisan bill working its way through Congress could have a major effect on how the Drug Enforcement Agency (DEA) classifies drugs under the Controlled Substances Act (CSA). The Improving Regulatory Transparency for New Medical Therapies Act (H.R. 639) was recently approved by the full House of Representatives and moved to the Senate, which has … Continue Reading

FDA Issues Draft Memorandum of Understanding for 503A Drug Compounding

Photo of Lee H. RosebushBy Lee H. Rosebush, Cory J. Fox and Dena Kessler on Posted in Uncategorized
Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate distribution of prescription compounded drugs—a Draft Memorandum of Understanding (MOU) between the FDA and each of the 50 states. As previously discussed, … Continue Reading

FDA Guidance Documents Change Compounding Landscape

Photo of Lee H. RosebushBy Lee H. Rosebush, Cory J. Fox, Nita Garg and Dena Kessler on Posted in Uncategorized
Almost a year and a half after adoption of the Drug Quality and Security Act (DQSA) in November 2013, which revised federal oversight of drug compounding, the Food and Drug Administration (FDA) continues to roll out guidance documents detailing its view on assorted issues concerning implementation of the statute. The FDA’s most recent offering is … Continue Reading

Proposed FDA Overhaul to Improve Biomedical Discovery and Development

Photo of Lance L. SheaBy Dena Kessler and Lance L. Shea on Posted in Uncategorized
The House of Representatives and the Senate are assessing significant reforms to the Food, Drug and Cosmetic Act. The reforms are aimed at accelerating the approval of new drugs, medical devices and other products regulated by the Food and Drug Administration (FDA). On January 27, 2015, the House Energy and Commerce Committee released draft legislation. … Continue Reading

A Step Forward in Approving Lower-Cost “Generic” Biologic Drugs

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States. Interestingly, generics of traditional drugs have been available in the U.S. for decades as a less expensive alternative to brand-name drugs and biosimilars have been available in Europe for several years. … Continue Reading

FDA Proposes Electronic Distribution of Prescribing Information

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
Drug manufacturers may no longer be required to distribute prescribing information on paper—with limited exceptions—and instead may have to distribute that same information electronically. The FDA recently issued a proposed rule that, if enacted, would require drug manufacturers to submit to the agency prescribing information to be posted on the FDA’s website, allowing the information to be … Continue Reading

New Guidance for 503B Outsourcing Facilities

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
Three guidance documents recently issued by the Food and Drug Administration (FDA) provide greater clarity for certain entities that compound sterile drugs. The new guidance addresses registration requirements, fees and drug reporting requirements for those entities registered as outsourcing facilities under Section 503B of the Federal Food, Drug and Cosmetic Act (FFDCA). Congress amended the … Continue Reading

Ebola and Emergency Access to FDA Unapproved Drugs in Life-Threatening Situations

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
As public health officials accelerate their efforts to develop a vaccine to combat Ebola—one that the U.S. Food and Drug Administration (FDA) has not yet approved for use—some may ask if there is ever an option for critically ill patients to gain access to unapproved drugs. These drugs can be obtained in very limited circumstances, … Continue Reading

It Is Finally Here─the Sun Shines on a New Era

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
The Centers for Medicare and Medicaid Services (CMS) publicly launched a database this week detailing the payments doctors and teaching hospitals have received from drug and medical device manufacturers. Under the Physician Payments Sunshine Act—a provision of the 2010 Affordable Care Act—CMS is required to collect and make available information about these payments, which certain manufacturers … Continue Reading

OIG Issues Special Advisory Bulletin Covering Manufacturer Copay Coupons and Medicare Part D

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
For years, many drug manufacturers have issued coupons to help cover some or all of the cost of copayments (commonly referred to as a “copay”) for prescription medications.  While the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has previously provided some guidance on the use of these coupons, there has … Continue Reading

DEA Authorizes Take-Back Programs for Pharmacies

Photo of Lee H. RosebushBy Dena Kessler and Lee H. Rosebush on Posted in Uncategorized
The U.S. Drug Enforcement Administration (DEA) recently issued a Final Rule expanding the facilities that can collect unused prescription drugs to now include retail pharmacies, hospitals and pharmaceutical manufacturers, as well as other specified entities. The Final Rule allows these entities to institute prescription drug take-back programs where patients can turn over unused pharmaceuticals either … Continue Reading
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