Compliance Resources to Help you Stay Current

340B Drug Pricing Program: Obama Administration Issues Much Awaited Final Rule

The Health Resources and Services Administration (HRSA) within HHS has lately issued a final rule that imposes civil monetary penalties on drug manufacturers for overcharging hospitals and clinics covered under 340B drug discount program. The HHS initially proposed the rule in June 2015, opened for comment and then extended the comment period.

FDA Issues Draft Regulatory Documents on Nutrition Facts Label and Serving Size

The U.S. FDA has recently released two draft guidance documents on Nutrition Facts Labeling and Serving Sizes to aid industry comply with the final rules issued by Agency in May 2016. The Final Nutrition Fact Label rule released in May 2016 marked the first comprehensive revamp of the label in 20 years.

Draft Document: WhatsApp and Skype May Come Under New EU Security Rules

Online communication giants WhatsApp and Skype may have to comply with stricter EU regulations by 2018. Telecom operators have long since complied with these regulations, and have often brought up the debate of the far more lightly regulated Apple, Google, Microsoft and Facebook services.

With similar services up on offer, companies that offer calls and messages through the internet, known as Over-The-Top (OTT), such as Facebook’s Whatsapp and Microsoft's Skype will also be expected to comply with EU regulations on handling customer data under its new security laws due soon.

Eurozone's Unemployment Rate Falls Below 10%

For the first time since 2011, unemployment rates dropped below 10 percent in the eurozone. Eurostat, an EU statistics agency, recorded the lowest rate in seven years - 9.9% in September, and a further dip from 9.8% in October.

The eurozone, also called the euro area, is a monetary union of 19 EU member states. This includes Austria, Belgium, Cyprus, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Slovakia, Slovenia, and Spain.

Aimed at spurring medical innovation, expanding mental health treatment, speeding up access to new drugs, and combatting opioid abuse, the bill, termed 21st Century Cures Act, promises plenty.

The US FDA recently amended its cGMP and labeling regulations for medical gases. The chief impetus for modifying the regulation was the number of injuries and deaths where medical gas containers carrying gases other than oxygen were falsely connected to a healthcare’s facility oxygen supply system.

FDA in the Federal Register said, “The final rule is intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container.”

Topping the global regulators' list of systemically important banks are Citi and JP Morgan, with HSBC vanquishing its spot to Citi and slipping down to accompany BNP Paribas, Deutsche Bank, and Bank of America.

A little in tune with President-elect Donald J. Trump’s proposed policies, the Internet Association sought his support in listing their priorities; key among them - immigration reform, stronger encryption, and ensuring liability protection for content that users share on their social platforms.

The US FDA recently held a 2-day public hearing to seek input for more flexible regulations on off-label promotion for drugs and devices. Pharmaceutical, medical device, and insurance industries, health and safety advocates, as well as physicians and patients packed a room for two full days at the FDA’s campus to debate on these rules and regulations.

Dr. Robert Califf, the FDA commissioner, said that ultimately, the analysis of the regulations is to ensure that the system "best protects and promotes the public health and the well-being of patients."

Pharmaceutical companies stated that current marketing regulations are too restrictive.

Patients argued that relaxing these regulations would be a "public health disaster."

The U.S. FDA has recently released two Food Safety Modernization Act (FSMA) compliance guidance documents to aid small businesses with the implementation of the Preventive Controls for Human Food and Preventive Controls for Animal Food rules.

The guidance summaries who need to comply with the rule, who is exempt from parts of the rules, and outlines key information for qualified facilities.

The US FDA has issued final guidance intended to assist FDA staff and those in the healthcare industry with submitting investigational device exemption (IDE) applications to conduct clinical trials for neurological medical devices.

The guidance applies to medical devices designed to target the cause or progression of neurological diseases, such as Alzheimer’s disease, Parkinson’s disease, or primary dystonia. The final guidance offers general study design considerations for clinical trials that investigate neurological devices using biological markers and clinical outcome assessments.

Credit risk, market risk, operational risk, counterparty credit risk, interest rate risk, and capital floors – a list of things on the itinerary for Basel IV. While yet adjusting to the requirements of Basel III, the newer legislation will hit the financial market soon enough, bringing with it a flurry of rules to mitigate any signs of a financial crisis akin to the 2007-2009 collapse.

Basel IV reaches up and sets the bar higher for capital adequacy – a move that has caused much discomfort in the EU financial industry. While the initially discussed model sought to increase the capital requirements of European banks by around 90 percent, talks are on for a number between 30 and 50 percent – a percentile still too high for comfort.

While regulators point out that the key to making profits in the pharmaceutical industry is innovation and breakthrough, they are left investigating an alternative that several industry giants seem to explore - price collusion.

Drug pricing practices in the pharma industry have drawn a lot of flak from various quarters and now lawmakers are turning their attention to this emerging trend. Price hikes at Valeant Pharmaceuticals, Mylan, and others are under close scrutiny, while federal antitrust regulators probe whether Merck & Co Inc, Sanofi SA, Novo Nordisk A/S, and Eli Lilly and Co colluded to fix prices for insulin and other diabetes drugs.

Elemental impurities have been topic of discussion since 2009 when the ICH commenced work to provide an international standard to limit the impurities in drug products and ingredients. FDA too has released its guidance on the control of elemental impurities in consistent with the implementation of ICH’s Q3D Elemental Impurities guideline. The FDA guidance also addresses the United States Pharmacopeial Convention’s (USP’s) requirements which go into effect on January 1, 2018.

On the agenda:

• With effect from 1 January 2017, updated haircut schedules for assets used as collateral in monetary policy operations
• Additional adjustments to haircut schedules to take effect by the end of 2017
• Measures aimed at maintaining adequate risk protection and improving consistency of the framework with a general minimal effect on aggregate collateral amount

With the view to ensure adequate risk protection, the ECB (European Central Bank) constantly reviews and makes adjustments to its collateral eligibility rules and its risk control measures applied while accepting collateral in the Eurosystem monetary policy operations. The Eurosystem refers to the monetary authority of the Eurozone - the EU member states that have adopted the euro as their official currency.

Health is a priority. No doubts about that. Fact, that people on this planet are getting more and more urges the healthcare landscape to create and adapt on enhancing the quality of patient care keeping low costs. Nowadays, you are linked from hospital administrator to hospital systems, hospital networks and so on. It is like a spider net - when you get in - it is hard to get out.

Pharmaceutical Quality by Design (QbD): Understanding its Principles

Quality is a prime factor of importance in this era of competition. More and more pharmaceutical companies today are embracing the principles of Quality by Design (QbD) for development and manufacturing. The principles of quality have been defined by three the ICH guidelines: Q8 on pharmaceutical development, Q9 on quality risk management and Q10 on pharmaceutical quality system.

QbD is a recent concept which has been included as an annex to ICH Q8 Guidance. QbD enables better process understanding, and a more scientific approach to development rather than mere testing of the final product.

GMA to FDA: Extend Timeline for Sodium Reduction Guidance

The Grocery Manufacturers Association (GMA), in comments submitted to the FDA regarding its sodium reduction guidelines, has urged FDA to extend its timeline for meeting short-term reduction goals from two to at least four years.

In June, the FDA issued draft sodium reduction guidance for the industry that are intended to help Americans gradually reduce sodium intake from the current average of 3,400 mg per day to 3,000 mg per day and eventually 2,300 mg per day. October 17 was the deadline for comments on the short-term targets.

DHS Issues Guidance on HIPAA and Cloud Computing

Cloud computing, an indelible part of healthcare systems and networks today, will now be regulated and brought under the HIPAA fold. DHS released the guidance that details the requirements for cloud computing service providers (CSP providers), clarifying that CSPs that create, receive, maintain, or transmit PHI (protected health information) on behalf of a business associate or covered entity are deemed business associates according to HIPAA.

FDA Releases Draft Guidance on Software as a Medical Device (SaMD): Clinical Evaluation

The US FDA has released the draft guidance on the clinical evaluation of software as a medical device (SaMD) prepared by the International Medical Device Regulators Forum (IMDRF). The Draft Guidance describes standards for determining the clinical validity by demonstrating the analytical validity, the scientific validity and clinical performance of the SaMD.