Dena Kessler

Dena Kessler

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

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...more

6/22/2015 - 21st Century Cures Initiative FDA Healthcare Medical Devices Medicare Medicare Part D Pending Legislation Pharmacies Prescription Drug Coverage Prescription Drugs Trade Associations

FDA Committee to Continue Considering Drug Compounding Issues

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...more

6/3/2015 - Advisory Committee DQSA Drug Compounding FDA FFDCA Healthcare Pharmaceutical Pharmaceutical Manufacturers

FDA Addresses Compounding of Animal Drugs From Bulk Drug Substances

The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more

5/22/2015 - Animal Drugs Draft Guidance Drug Compounding FDA FFDCA

FDA Finalizes Guidance Documents on Biosimilars

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...more

5/15/2015 - Biosimilars BPCIA FDA Final Guidance Pharmaceutical Pharmaceutical Manufacturers

Compounding Pharmacies Protected by Medical Liability Act

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...more

5/15/2015 - Drug Compounding Healthcare Malpractice Claims Pharmacies

Latest Spike in Prescription Drug Spending Prompts OIG Investigation

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...more

4/23/2015 - Generic Drugs Government Investigations Medicaid OIG Pharmaceutical Manufacturers Prescription Drugs

CMS Fines Insurer for Misleading Medicare Part D Beneficiaries

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...more

4/21/2015 - Aetna CMS Health Insurance Medicare Medicare Part D Misrepresentation Prescription Drugs

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

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...more

4/21/2015 - Healthcare HRSA OMB Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Proposed Regulation Rulemaking Process Section 340B

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

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...more

4/2/2015 - Controlled Substances Act DEA FDA Pending Legislation

FDA Issues Draft Memorandum of Understanding for 503A Drug Compounding

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...more

3/10/2015 - Drug Compounding FDA FFDCA Healthcare Interstate Commerce Memorandum of Understanding New Guidance Pharmaceutical Pharmacies

FDA Guidance Documents Change Compounding Landscape

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...more

3/9/2015 - DQSA Drug Compounding FDA FFDCA Healthcare New Guidance Outsourcing Outsourcing Facilities Pharmaceutical

Proposed FDA Overhaul to Improve Biomedical Discovery and Development

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...more

2/16/2015 - Drug Manufacturers FDA Healthcare Healthcare Reform Medical Devices Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Proposed Legislation

FDA Proposes Electronic Distribution of Prescribing Information

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...more

1/28/2015 - Electronic Communications Electronically Stored Information FDA Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Proposed Regulation Websites

FDA Clarifies Orphan Drug Exclusivity Policy Following Court Defeat

On the heels of a loss in federal court last fall, the FDA recently announced a clarification of its policy concerning orphan drug exclusivity. In short, despite a court ruling requiring the FDA to grant orphan drug...more

1/27/2015 - FDA Marketing Orphan Drugs Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Product Exclusivity Summary Judgment

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

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...more

1/26/2015 - Affordable Care Act Biosimilars BPCI FDA Generic Drugs Novartis Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs

New Guidance for 503B Outsourcing Facilities

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...more

12/2/2014 - Drug Compounding FDA FFDCA New Guidance Pharmacies Registration

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

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...more

11/3/2014 - Drugs Ebola FDA Healthcare Medical Emergencies

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

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...more

10/6/2014 - Affordable Care Act CMS Health Care Providers Hospitals Manufacturers Pharmaceutical Manufacturers Physician Medicare Reimbursements Sunshine Act

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

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...more

9/22/2014 - Anti-Kickback Statute Co-payments False Claims Act Medicare Medicare Part D OIG Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs

DEA Authorizes Take-Back Programs for Pharmacies

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...more

9/15/2014 - DEA Pharmaceutical Pharmacies Prescription Drugs

Recent Updates on Reimbursing Creditors' Legal Fees Under a Chapter 11 Plan

Unsecured creditors in chapter 11 cases face the prospect of two financial blows: the possibility of not receiving full payment of their claims and the cost of attorney's fees for defending their interests....more

6/21/2013 - Attorney's Fees Chapter 11 Creditors Legal Costs Reimbursements

Always Be Prepared: Forecasting a Business Partner's Financial Problems and How to Prepare

As the American economy continues to slog through the ongoing Great Recession, even financially sound companies face challenges due to the continued economic malaise. In particular, a company that works with suppliers,...more

4/19/2013 - Adequate Assurances Business Development Client Services Contract Claims Creditors Debtors Fraud Insolvency Licenses Unsecured Creditors

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