Tag archives: life sciences

The UK Government’s Brexit White Paper and its impact on the life sciences sector

On February 2, 2017, the Government published a White Paper on its plan for exiting and achieving a new partnership with the EU. The White Paper expands upon Prime Minister Theresa May’s speech on January 17, 2017. We have previously written about the speech and earlier developments (The UK government’s Brexit plan and its implications for Life Sciences). See … Continue reading

New USPTO subject matter eligibility (35 USC § 101) examiner guidance and life science examples

On May 5, 2016, the United States Patent and Trademark Office issued six new examples that provide guidance to Examiners and patent applicants prosecuting claims directed to life sciences subject matter (Subject Matter Eligibility Examples: Life Sciences).  These examples analyze claims that are directed to several of the most contentious areas of patentable subject matter … Continue reading

Third Circuit extends Actavis to non-cash reverse payments

On June 26, the Third Circuit ruled that so-called “reverse payment” settlement agreements of patent infringement litigation between branded and generic pharmaceutical companies can face antitrust scrutiny under the Supreme Court’s decision in FTC v. Actavis, even when the “payment” at issue is an agreement by the branded company not to market an authorized generic … Continue reading

CMS releases 2014 Sunshine Act data

On schedule, CMS released the 2014 Sunshine Act data, which shows $6.49 billion in transfers of value by pharmaceutical and medical-device manufacturers to physicians and teaching hospitals.  The data covers 11.4 million financial transactions attributed to over 600,000 physicians and more than 1,100 teaching hospitals. Join us on July 8 or July 14 for a … Continue reading

FDA issues 48 product-specific bioequivalence recommendations for generic drugs

On June 29, 2015, FDA released 44 new and 4 revised product-specific bioequivalence recommendations for the development of generic drugs.  FDA has now published a total of 1321 bioequivalence recommendations, listed by the active ingredient, on its website. Under 21 CFR 320.24, applicants must conduct bioequivalence testing using the most accurate, sensitive, and reproducible approach … Continue reading

Government gears up: Sunshine data informs investigations and inquiries

This week at an enforcement panel, government representatives discussed using the Sunshine Act data to delve into allegations of kickbacks to doctors and detect industry trends of improper behavior. During the American Conference Institute’s 7th Annual Forum on Sunshine Act Compliance & Aggregate Spend Reporting, government representatives recognized that industry payments to physicians may be … Continue reading

Norton Rose Fulbright launches 2015 litigation trends annual survey

We recently released our 2015 litigation trends annual survey, the 11th overall and the most extensive in its history. More than 800 corporate counsel representing companies across 26 countries were polled on disputes-related issues and concerns. Click here to read our press release, and click here to see Law360’s extensive coverage. Survey respondents – primarily … Continue reading

Broad interpretation of France’s Sunshine Act continues global trend toward transparency

Beyond the United States’ Physician Payments Sunshine Act reporting requirements, international pharmaceutical and device companies must account for a growing number of transparency requirements related to their interactions with healthcare professionals. For example, in France, the Bertrand Act requires transparency related to: (1) the agreements between companies and healthcare professionals (HCPs) and (2) any benefits, … Continue reading

FDA releases guidance to clarify procedure for changes to previously-approved REMS applications

Earlier this week, the U.S. Food and Drug Administration (FDA) released guidance on the definition and processing of submissions for modifications and revisions to approved pharmaceutical risk evaluation and mitigation strategies (REMS). REMS are strategies to manage a known or potential serious risk associated with a drug or biological product. FDA has the authority to … Continue reading

Sunshine Act data submission / correction begins today

Starting today, applicable manufacturers and GPOs can begin submitting data about Sunshine Act payments and transfers of value for the 2014 calendar year, according to a listserv email from CMS. Applicable manufacturers and GPOs can also submit corrected 2013 data, as needed, until the March 31, 2015 deadline for data submission. Physicians and teaching hospitals … Continue reading

Preventing pharmaceutical fraud: what’s on the horizon for Australia?

The possible introduction of a United States-type False Claims Act (FCA) in Australia will see a sharp increase in allegations of fraudulent conduct in many industries, particularly for those in the pharmaceutical industry. The cost of fraud to the public purse arising from fraud is well documented. Many of the large-scale cases of fraud successfully … Continue reading

Top things you should know about the Sunshine Act database

The shifting guidance on whether the industry should report mere funding of educational events, the likely enforcement ahead by federal and state agencies, and maps showing the “hotspots” of consulting, food and beverage, and travel and lodging payments: here’s what you should know now about the Sunshine Act / Open Payments database. The indirect-payment exclusion … Continue reading

Ranbaxy Pharmaceuticals to pay US$39.75m to resolve Texas Medicaid fraud enforcement action

On October 16, the Texas Office of Attorney General settled an enforcement action against Ranbaxy, an Indian manufacturer of generic drugs. The settlement resolves the State’s lawsuit under the Texas Medicaid Fraud Prevention Act (“TMFPA”) against Ranbaxy for allegedly reporting inflated drug prices to the State Medicaid program. The settlement agreement requires Ranbaxy to pay … Continue reading

Sunshine around the world

In the United States, the healthcare industry is familiar with the Sunshine Act’s tracking and reporting requirements related to payments and transfers of value to physicians, as well as to physician ownership and investment interests. And around the world, new rules and policies are seeking to increase transparency. For example, the Norton Rose Fulbright’s UK briefing, … Continue reading

Sunshine Act data now available

The “Open Payments” database of transactions reported under the Physician Payments Sunshine Act has launched on its scheduled release date of September 30 and is now available for public review. Pharmaceutical and medical-device manufacturers reported information about their financial relationships with physicians and teaching hospitals for the second half of 2013 to the Centers for … Continue reading

Drugmakers liable for improper copay coupon use

Pharmaceutical manufacturers have primary responsibility for ensuring that Medicare Part D members do not redeem copay coupons that could trigger federal inducement prohibitions, according to a report and Special Advisory Bulletin released on September 19 by the Office of Inspector General at the US Department of Health and Human Services (OIG). The OIG, relying on … Continue reading

Sunshine data 33 percent unpublishable, penalties next?

Despite extending the dispute-and-resolution deadline to account for the days that the Centers for Medicare & Medicaid Services (CMS) pulled down the reporting system, the public Physician Payments Sunshine Act website is still expected to go live in a matter of weeks. It now seems, however, that CMS will publish only two-thirds of the reported … Continue reading

No sanctions on direct-to-patient product-sales program

The Office of Inspector General (OIG) has concluded that it would not impose sanctions on a pharmaceutical manufacturer for operating a direct-to-patient product-sales program that allows certain customers to purchase a manufacturer’s brand-name product for a fixed cash price from an online retail pharmacy vendor outside of any applicable prescription-drug insurance benefit. See OIG Advisory Opinion No. … Continue reading

FDA releases draft guidance on the use of social media for the promotion of drugs and devices

The FDA has also released draft guidance describing its current thinking regarding the dissemination of benefit and risk information for drugs and medical devices on social media platforms with character space limitations, including Twitter and sponsored internet advertisements.  The FDA stated that this draft guidance does not apply to the promotion of drugs and medical … Continue reading

Phase 2 reporting opens June 1

By listserv message, CMS announced that applicable manufacturers and applicable group purchasing organizations (“GPOs”) can start Phase 2 of Open Payments registration and detailed data submission process on June 1. Phase 2 itself has two steps and Phase 2 closes on June 30, 2014: Step 1: Starting June 1 Applicable manufacturers and applicable GPOs must complete system registration and confirm … Continue reading

FDA cracks down on drug maker’s Facebook page

On March 12th, the FDA published a letter it had sent last month to Switzerland-based drug maker IBSA Institut Biochimique SA regarding the false and misleading nature of a Facebook page for the company’s drug, Tirosint. Specifically, the FDA’s Office of Prescription Drug Promotion (“OPDP”) found that the Facebook page was false and misleading because … Continue reading
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