Tag Archives: cmsDrugs

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for approving innovative drugs and medical devices, and to address other issues, including those regarding clinical trial design, research funding, and … Continue Reading

Alameda Drug Disposal Ordinance: Supreme Court Denies Petition for Writ

The United States Supreme Court has declined to hear a challenge to the Alameda County Drug Disposal Ordinance (“Ordinance”) brought by three pharmaceutical trade organizations.  The Court’s decision leaves in force the Ninth Circuit decision, which found that the Ordinance, requiring pharmaceutical manufacturers to fund drug take-back programs in the county, did not interfere with … Continue Reading

Proposed 21st Century Cures Act Addresses Off-Label Promotion Issues for Drugs and Devices

Over on the Health Industry Washington Watch blog, Reed Smith attorneys Katie Pawlitz and Jeremy Alexander highlight the proposed changes to the Sunshine Act contained within H.R. 6, the “21st Century Cures Act,” which (as previously reported on Life Sciences Legal Update) was approved by the House Energy and Commerce Committee last Thursday, May 21, … Continue Reading

OIG Report: FDA Has Made Progress on Oversight/Inspections of Manufacturers of Generic Drugs

On May 5, the Office of Inspector General (OIG) issued a report entitled "FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs" in response to a Congressional request expressing concerns about the safety and quality of generic drugs produced by manufacturers outside the United States. The OIG report contains an analysis of FDA's inspections of generic drug manufacturers over the past several years, and provides several recommendations for the FDA going forward.… Continue Reading

Bipartisan Energy & Commerce Committee Leaders Release Updated 21st Century Cures Draft

The bipartisan leadership of the House Energy and Commerce Committee has released their 2015 version of the 21st Century Cures Act, which is intended to bolster medical discovery, treatment development and delivery of treatment to patients. The nearly 200-page legislation is the product of a year-long collaboration between lawmakers and stakeholders.… Continue Reading

The SEC and the Pharmaceutical Industry – Recent Commentary by the SEC’s Enforcement Director Identifies Areas of SEC Focus Applicable to the Industry

Andrew Ceresney, enforcement director of the U.S. Securities and Exchange Commission (SEC), recently gave a presentation at CBI's Annual Pharmaceutical Compliance Congress in which he highlighted three current areas of SEC focus most relevant to the pharmaceutical industry: the Foreign Corrupt Practices Act, corporate disclosures relating to interactions with the Food and Drug Administration, and financial internal controls.… Continue Reading

FDA Draft Guidance Addresses Electronic Informed Consent in Clinical Investigations

FDA has issued a draft guidance providing recommendations for clinical investigators, sponsors and institutional review boards on the use of electronic informed consent for FDA-regulated clinical investigations of medical products, including drugs, medical devices and biological products. FDA is accepting comments on the draft guidance until May 8, 2015. In addition, the HHS Office for Human Research Protections (OHRP) is considering whether to adopt the positions and recommendations proposed in this guidance for research regulated under the HHS protection of human subjects regulations and to issue a joint OHRP/FDA guidance document on this topic once the FDA's final guidance document has been developed.… Continue Reading

Recent Regulatory Actions on Advertisement Disclosures

An article in Compliance Week discusses recent actions by the Federal Trade Commission (FTC) and Food and Drug Administration concerning advertisement disclosures. The FTC launched Operation Full Disclosure in fall 2014, which involved sending warning letters to more than 60 companies across "a wide range of industries" for failing to properly disclose information in their advertisements. These letters serve as a reminder to all companies, even those that did not receive letters, to review their disclosures in order to minimize the likelihood of a violation in the future.… Continue Reading

U.S. Congressional Committees Address Drug And Device Approval

As mentioned on our Health Industry Washington Watch blog, committees in both the House of Representatives and Senate last week addressed the speed at which medical innovations are approved and available for patient use. The House Energy and Commerce Committee’s “21st Century Cures Act” discussion draft, released on January 27, 2015, is a wide-reaching bill … Continue Reading

Drug Disposal Ordinance: Supreme Court Writ Filed

The Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and the Generic Pharmaceutical Association (GPhA) have jointly filed a Petition for a Writ of Certiorari with the U.S. Supreme Court, asking for review of the Ninth Circuit's decision in PhRMA v. County of Alameda, in which the court ruled that Alameda County's Safe Drug Disposal Ordinance - requiring pharmaceutical manufacturers to establish or participate in a program for collecting unwanted prescription drugs from consumers - was constitutional.… Continue Reading

County Ordinances Place Responsibility for Collection of Unwanted Pharmaceuticals on Manufacturers

The Alameda County (CA) Safe Drug Disposal Ordinance (Alameda County Code Chapter 6.53, §§ 6.53.010-6.53.120) is one of several county-wide regulations across the United States to enforce the establishment of and/or participation in Product Stewardship Plans on the part of pharmaceutical manufacturers, with the ultimate goal of collecting unwanted drugs for purposes of disposal. The … Continue Reading

Proposed Rule Re Submitting Clinical Trial Registration and Results, Including Adverse Event Information, To ClinicalTrials.gov Database

The National Institutes of Health has released a proposed rule designed to provide clarity on the requirements surrounding the submission of information to ClinicalTrials.gov, as mandated by the Food and Drug Administration Amendments Act of 2007. Among these requirements is the submission of summary results for clinical trials involving all pharmaceuticals, medical devices and biological products, regardless of whether they have been approved, licensed or cleared by the Food and Drug Administration. The rule also provides timetable restrictions for the registration of a clinical trial and submission of summary results, as well as guidelines for the reporting of adverse events.… Continue Reading

Proposed HELP Committee Bill Aims to Incentivize Development of Ebola Treatments and Vaccines

In light of the recent Ebola outbreak and concerns over health safety, members of the U.S. Senate’s Health, Education, Labor, and Pensions (HELP) Committee have introduced a bill that would add Ebola to the Food and Drug Administration’s (FDA) priority review voucher program, which is designed as an incentive for developers of treatments and vaccines … Continue Reading

Reed Smith Team Analyzes OIG’s Proposed Rule Amending Anti-Kickback Safe Harbors, CMP Rules & Gainsharing Regulations

The Office of Inspector General (OIG) of the Department of Health and Human Services published a major proposed rule on October 3, 2014 amending the Anti-Kickback Statute (AKS) safe harbors and the Civil Monetary Penalty (CMP) rules to protect a number of payment practices not previously allowed under those regulations. The proposed rule and the … Continue Reading

Omnicare’s Appellate Victory Upheld by U.S. Supreme Court

The February 2014 decision (discussed in an earlier blog post) in which the U.S. Court of Appeals for the Fourth Circuit dismissed the False Claims Act (FCA) charges brought in United States ex rel. Rostholder v. Omnicare, Inc. was confirmed on October 6, 2014, when the U.S. Supreme Court declined to review the Rostholder decision. … Continue Reading

Was It Worth the Wait? – FDA Releases Two Social Media Guidance Documents for Drug/Device Industry

Earlier this week, the FDA issued two draft guidances on social media, and Reed Smith attorneys Colleen Davies, Celeste Letourneau, Kevin Madagan, and Jennifer Pike have written a client alert that analyzes them both in detail. The first guidance pertains to product claims and risk information on platforms like Twitter and sponsored links, and the second to correcting third party misinformation that appears in social media, such as in comments on a Facebook page or website. A key date to keep in mind is that the deadline for comments is September 16, 2014.… Continue Reading

Do You Know Where Your Pharmaceuticals Are From? Navigating the “Country of Origin” Question for Pharmaceutical Products

Drug and medical device manufacturers are often faced with difficult challenges in determining the country of origin for their products, which are often sourced, processed and manufactured in multiple countries. As detailed by the article "Origin of the Pieces: How to Determine a Pharmaceutical Product's 'Country of Origin,'" written by Reed Smith lawyers Jeffrey Orenstein and Lorraine Campos, there are a variety of factors that must be taken into consideration when answering the country of origin question for a pharmaceutical product - chief among which is who is asking the question. This article provides an overview of the principal regulatory schemes and their country of origin standards in order to help provide clarity to pharmaceutical companies in an often confusing and frustrating process.… Continue Reading

FDA Draft Guidance Encourages Companies to Study Drugs for Treatment of CFS and ME and Provides Roadmap to Approval for this Indication

The FDA recently released draft guidance designed to accelerate the development and review process for drugs intended to treat Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), a condition for which there is currently no FDA-approved treatment. Though non-binding, the guidance should help drug manufacturers design and execute studies that are more likely to succeed in satisfying the FDA clearance requirements that there be "substantial evidence" of the efficacy of a product and an acceptable risk/benefit profile. The guidance will become finalized following the end of its notice/comment period on May 12, 2014.… Continue Reading

Fourth Circuit dismisses False Claims Act case based on FDA cGMP Violations

Reed Smith Partner Larry Sher authored a post on the Drug and Device Law Blog about a recent decision in which the U.S. Court of Appeals for the Fourth Circuit affirmed the dismissal of a False Claims Act (“FCA”) case brought against Omnicare, United States ex rel. Rostholder v. Omnicare, Inc., No. 12-2431, 2014 WL 661351 … Continue Reading

D.C. Circuit Decision Upholds DOD Rule, Potentially Leaving Pharmaceutical Manufacturers on the Hook for Refunds

In a recent decision, the D.C. Circuit upheld a Department of Defense ("DOD") rule that will require drug manufacturers to provide partial refunds on some prescription drugs, dating back to 2008. The rule that was in question in the case imposes a cap on the retail price of drugs and requires manufacturers to refund the difference between the retail price and the discounted rate of the pharmaceutical drug benefits the DOD provides through TRICARE.… Continue Reading