Life Science Compliance Update

September 19, 2017

Study Released on Comparison of International Regulatory Authorities



Pharmaceutical regulations vary widely across the world, and while our sister publication, Life Science Compliance Update, keeps compliance professionals abreast of new development and comparisons across continents and countries, an article published August 2017 in Nature Reviews Drug Discovery offers comparisons in terms of the regulators’ budgets, staff, new drug approvals and timelines for approvals.


Of the regulators in the more established major pharmaceutical markets (in this study, the United States, Europe and Japan are considered the regulators in such markets), the United States Food and Drug Administration (FDA) has the most internal reviewers (an estimated 2,000), though the European Medicines Agency (EMA) has a network of more than 4,500 experts providing scientific expertise to the agency.


Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), meanwhile, has about 560 reviewers, while the China Food and Drug Administration (CFDA) had only about 120 staff in its Center of Drug Evaluation to perform scientific evaluations through August 2015. Since August 2015, the research says the State Council of China has brought that number up to about 300 to work through a backlog of applications. 


As far as new drug application (NDA) submissions and approvals, differing NDA definitions or their equivalents between authorities make direct comparisons difficult, though in the established markets, the FDA was noted as approving the most NDAs for new drugs (45) in 2015, while Japan’s PMDA approved the most NDAs (48) in 2016. 


Similarly, timelines to NDA approval have different definitions and processes, though the researchers said the shortest time to market was 210 calendar days for EMA and the longest was 900 calendar days for CFDA (though CFDA is trying to accelerate that process). Several of the authorities also have programs to enable accelerated review of products that are considered to be addressing particularly important medical needs, such as the FDA's priority review designation, which is associated with a review timeline of 180 days, compared with the standard review timeline of 300 days.


NDA review fees also vary, the authors reported, noting India had the lowest fees (50,000 Indian rupees; ~$1,000), whereas FDA had the highest ($2.3 million). 


"Overall, the regulatory authorities in developed countries such as the United States, European Union, UK, Canada and Japan are more evolved in terms of regulatory systems and resources, such as technical reviewers, but have higher NDA fees," the authors wrote.




September 18, 2017

PhRMA and Bio Sue Nevada


On September 2, 2017, Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) filed a lawsuit challenging the constitutionality of Nevada’s first-in-the-nation insulin transparency law. The two groups allege that implementing the law would violate patient rights and nullify trade secret protections. PhRMA and BIO are asking the U.S. District Court to declare that provisions of the Nevada law, passed during the 2017 legislative session, are preempted by federal law and violate the U.S. Constitution.

The complaint alleges that the law violates the Taking Clause of the Fifth Amendment – which prohibits the government from taking private property without just compensation – and the Commerce Clause – which bars the states from interfering with commerce in other states. For good measure, the complaint also alleges that the law violates federal patent law and trade secret law, stating the legislation removes trade secret protections for highly sensitive information and improperly infringes on federal authority over patent rules.

The groups said the new law also requires the state to publish company-specific reports of information disclosed on a public website. If that is done, then the trade secret is no longer secret and will lose its value – not only in Nevada but also throughout the nation.

The complaint also cites Gov. Brian Sandoval’s veto of the original version of the insulin transparency bill. Sandoval believed that Cancela’s bill too narrowly focused on the role that pharmaceutical manufacturers play in setting drug prices without requiring the same level of transparency from the middlemen in the drug pricing process, known as pharmacy benefit managers. PBMs, the go-between on drug costs for manufacturers, insurance companies and pharmacies, negotiate discounts with and receive rebates from manufacturers but aren’t required to disclose how much of those savings they pass along to insurers and how much they keep for themselves.

The complaint refers to Sandoval’s veto in which he noted that the original bill posed “serious risks of unintended and potentially detrimental consequences for Nevada’s consumer patients, not the least of which is the possibility that access to critical care will become more expensive, more restricted and less equitable.”

State officials have tried to emphasize to manufacturers during the implementation process that the goal of the law is to gather information to help policymakers make good health care policy decisions and so consumers can make good choices about their own health care. Since the end of the legislative session, officials with the state Department of Health and Human Services have been in active communication with PhRMA, BIO and individual pharmaceutical manufacturers, who the state characterized as “cooperative” earlier this week.

PhRMA and BIO Statements

“Nevada’s law is, in actuality, an attempt to set de facto price controls on the few successful products that do make it to market, and in doing so, it will chill the massive private investment needed to spur our amazing biomedical innovation ecosystem that is providing hope to patients in Nevada and throughout the world,” said Tom DiLenge, BIO’s president for advocacy, law, and public policy.

“If provisions of SB 539 go unchallenged, then Nevada’s law will conflict with and in many cases override federal law and the laws of 49 other states – laws that foster pharmaceutical innovation and protect intellectual property and trade secrets. For this reason and others, provisions of SB 539 are unconstitutional and should not be implemented,” said PhRMA Executive Vice President and General Counsel James Stansel.

Ohio Drug Distribution Verification: America’s Key Battleground State Shakes Up the Pharmaceutical Supply Chain


The pharmaceutical industry faces monumental challenges in the age of globalization within the United States: state laws and regulations that are more stringent than their federal counterparts. This article provides the historical context and current overview of Ohio’s laws, regulations, and sub-regulatory guidance concerning the distribution of prescription drugs, including drug samples, into and within the state, the verification requirements when distributing product to terminal distributors of dangerous drugs and prescribers, record retention responsibilities, and penalties for noncompliance. The article then examines the industry’s response from a major manufacturer, a distributor/third-party logistics provider, verification vendor, and compliance advisory vendors. It concludes with a call to action to the industry to form a new coalition to address state legislative and regulatory actions that have the potential to disrupt the entire supply chain.

The pharmaceutical industry faces a major dilemma: active state legislatures, administrative agencies, and state attorney generals. There is a plethora of reasons why states have turned their attention towards the manufacturers and trading partners, such as wholesale distributors and third-party logistics providers (“3PLs”). There is an opioid crisis gripping the nation, an ever-growing increase in healthcare costs, unstoppable negative publicity aimed at the pharmaceutical industry, an emboldened citizenry demanding their legislatures to do something, hospital and insurance lobbies joining the fight. As a result, state politicians are using all of this to their advantage to pass laws aimed at the industry.

This article discusses a law that has been on the books for over forty years, and amended numerous times, including a 2017 revision that lead to Ohio becoming pharma’s “key battleground state.”

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