Lee H. Rosebush

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Otsuka Suit Results in Victory for FDA

According to a recent decision by a Maryland federal court, the Food and Drug Administration (FDA) acted permissibly when it approved generic versions of Otsuka Pharmaceutical Co. Ltd.’s (Otsuka) product Abilify even though Otsuka retained marketing exclusivity for the drug. This ruling was the most recent in a series of decisions regarding the FDA’s decision … Continue Reading

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 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

Amarin Pharma Sues FDA Over Constitutional Right to Discuss Off-Label Uses

Drug makers and the Food and Drug Administration (FDA) have often disagreed over whether drug makers can discuss unapproved uses for their products with physicians. While courts have sided with drug makers in certain situations, the federal government (including the FDA, HHS-OIG, and DOJ) still holds policies and positions that disapprove of the practice. In … Continue Reading

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 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

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

New Data on Part D Prescription Drugs Available

On April 30, 2015, the Centers for Medicare & Medicaid Services (CMS) made available a dataset that provides detailed information on medications that physicians and other healthcare providers prescribed under the Medicare Part D Prescription Drug Program in 2013. CMS intends for this dataset to provide “key information to consumers, providers, researchers, and other stakeholders … Continue Reading

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 spending growth reached 17 percent. According to the report, the most significant driver of medication spending was not the newly-insured … Continue Reading

Following FDA’s First Biosimilar License, CMS Issues Guidance on Reimbursement for Biosimilars

On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number of guidance documents addressing reimbursement for biosimilars under the Medicare Part B, Part D, and Medicaid programs. This is an initial step for CMS, and more guidance is likely … Continue Reading

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 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

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

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 Establishes Docket for Public Comments on Drug Compounding

The Food and Drug Administration (FDA) recently announced a new docket for public comments on the compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA hopes that these public comments will provide insight on stakeholders’ experience and views regarding drug compounding as the … Continue Reading

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 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

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

Medicare Advantage and Medicare Part D Changes for 2016 Released

On February 6, 2015, the Centers for Medicare & Medicaid Services (CMS) released a final rule regarding changes to Medicare Advantage and Medicare Part D to take effect in 2016. According to CMS, this final rule “implements statutory requirements, improves program efficiencies, strengthens beneficiary protections, clarifies program requirements, improves payment accuracy, and makes technical changes … Continue Reading

Now’s the Time to Comment on the FDA’s New Draft Documents on Compounding Policy

The U.S. Food and Drug Administration (FDA) has released five new draft documents related to drug compounding and repackaging by “outsourcing facilities,” state-licensed pharmacies, federal facilities and other healthcare entities. These documents are the latest in a series of policy guidance, including the documents released in July 2014 and December 2014, issued as part of the … Continue Reading

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 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

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

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

Pharmacy Benefit Manager Faces Lawsuit by Compounding Pharmacies

In response to a decision to deny coverage of approximately 1,000 active ingredients that are widely used by compounding pharmacies to create topical treatments, three compounding pharmacies have filed a lawsuit against the pharmacy benefit manager (PBM) at the center of the dispute. The lawsuit alleges that Express Scripts is illegally denying prescriptions and causing … Continue Reading

HRSA Withdraws Proposed “Mega Rule” for 340B Drug Pricing Program

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), has withdrawn a proposed omnibus rule, referred to as the “mega rule,” for the 340B Drug Pricing Program. The mega rule was expected to cover contract pharmacy compliance and eligibility criteria for patients, hospitals and off-campus … Continue Reading

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 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

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
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