Lee H. Rosebush

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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Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), has withdrawn a proposed omnibus rule, referred to as the “mega rule,” for the 340B Drug Pricing Program.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

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments.  Beginning September 29, 2014, the public will have an additional thirty (30) days to provide comments on the following guidance documents:  (1) Internet/Social Media … Continue Reading

Purple Is the New Orange

Last week, the Food and Drug Administration (FDA) announced that it has published a list of licensed biological products and interchangeable biosimilars to be known as the Purple Book. The Purple Book is meant to be the biological equivalent of the pharmaceutical “Orange Book,” which is used by government agencies and healthcare providers to identify … Continue Reading

FDA Regulation of Laboratory Developed Tests on the Horizon

At a contentious hearing of the House Energy and Commerce Health Subcommittee on September 9, 2014, lawmakers and the Food and Drug Administration (FDA) clashed over proposed guidance from the FDA regarding the regulation of laboratory developed tests (LDTs). Under the Food and Drug Administration Safety and Innovation Act of 2012, the FDA is required … Continue Reading

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 (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

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

Implications on Pharmacies of Recent OIG Advisory Opinion on Per-Fill Fees

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently issued an advisory opinion regarding a proposed arrangement by a specialty pharmacy (Requestor) to pay local pharmacies a per-fill fee for the provision of support services in connection with patient referrals to the specialty pharmacy. OIG found that this per-fill fee … Continue Reading

Compounded Drugs and Medicare Part B: OIG Report Recommends Payment and Oversight Changes

The U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently published a report titled “Compounded Drugs Under Medicare Part B: Payment and Oversight” (Report) in which it recommended that the Centers for Medicare & Medicaid Services (CMS) implement changes to the way Medicare Part B claims for compounded drugs … Continue Reading

FDA Releases Compounding Policy Documents

The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, as … Continue Reading

The Orphan Drug Wars: HHS’s Rebuttal to Its Recent Loss to PhRMA

On June 18, 2014, the U.S. Department of Health and Human Services (HHS) publicly stated that the recent decision of the U.S. District Court for the District of Columbia to vacate HHS’s regulation covering orphan drugs and the Section 340B Drug Pricing Program (340B Program), would not prevent the agency from moving forward with its … Continue Reading

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an injunction and the granting of a motion for summary judgment brought by the Pharmaceutical Research and … Continue Reading

Stop the Presses! Senate Directs FDA to Meet With Stakeholders Before Enforcing Compounding Law

As previously discussed, the recent flurry of U.S. Food and Drug Administration (FDA) activity following passage of the Drug Quality and Security Act (DQSA) in November 2013, including the issuance of three draft guidance documents and six warning letters in the span of just a few months, has resulted in several important unanswered questions as … Continue Reading

FDA Regulation of Compounding Pharmacies: Unsolved Mysteries

The U.S. Food and Drug Administration (FDA) has been busy since the passage of the Drug Quality and Security Act (DQSA) in November 2013. In just five short months, the FDA has issued six warning letters referencing the DQSA’s outsourcing facility provisions, published three draft guidance documents outlining its authority and enforcement priorities under Sections … Continue Reading

Senate Passes “Drug Quality and Security Act”

On November 18, 2013, the Senate, by voice vote, approved the Drug Quality and Security Act (DQSA), intended to bolster the Food and Drug Administration’s (FDA) oversight of compounding pharmacies in light of last year’s unfortunate incidents involving compounded medications and meningitis. The DQSA has received significant bipartisan support since its introduction and approval by … Continue Reading

Regulation of Compounding Pharmacies Continues to Evolve with House Passage of “Drug Quality and Security Act”

In the current environment it seems that few, if any, pieces of legislation are moving through Capitol Hill. However, there is one area that has seen significant activity: the regulation of compounding pharmacies. Specifically, there has been bipartisan support for legislation intended to bolster the Food and Drug Administration’s (FDA) oversight of compounding pharmacies in … Continue Reading

After Recalls, Pharmacies Wonder How Well They REALLY Know Their Subcontractors

Pharmacy compounding has been a very hot topic over the last 12 months. Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration (FDA) or action by a state board of pharmacy, the world of compounding is rapidly changing, and many pharmacies are turning to subcontractors for their … Continue Reading
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