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By: Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs and Mark Abdoo, Associate Commissioner for Global Policy and Strategy

The European Union (EU) is one of the U.S. Food and Drug Administrations most important collaborators in tackling public heath challenges. The FDA and the European Commission (EC) and its European Medicines Agency (EMA) have long leveraged each others expertise and experience to promote the safety, effectiveness, and quality of medical products to advance the health of our citizens. Now, our work, built together over more than a decade, has paved the way for a multitude of critical collaborations on many scientific and regulatory fronts as part of our COVID-19 response.

What has helped drive this collaboration are the 30 technical expert groups, or clusters that the FDA and the EMA have established since 2003. These clusters meet regularly for regulatory discussions held under confidentiality commitments and were well positioned to pivot to focus on COVID-19 because of our ongoing work together. Since the start of the pandemic, many of these groups which often also include regulatory authorities from Japan, Canada, Australia, and other countries have shifted their work priorities to focus on COVID-19. For example, our expert group on vaccines has expanded into a multilateral forum to discuss regulatory issues related to the development of SARS-CoV-2 vaccines, whereas the pharmacovigilance group has begun to identify opportunities for collaboration on observational studies related to COVID-19 natural history and interventions. Similarly, our standing meetings on blood products are now focusing on developments related to COVID-19 convalescent plasma. The drug shortages discussions revolve around information sharing on strategies for COVID-19 related shortages and supply disruptions of medicines.

In these expert group discussions, the FDA and the EMA have been exchanging information on the rapidly evolving scientific landscape of products and clinical trials and, as possible, discussing the interpretation of data supporting regulatory decisions. For example, two days after the release of results from a clinical trial that the National Institute of Allergies and Infectious Diseases (NIAID-ACTT study) conducted, the FDA authorized the emergency use of the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. The FDA subsequently hosted a virtual meeting of key regulatory partners, including from Europe, Canada, and Japan, to discuss the safety and efficacy of remdesivir as a treatment for COVID-19. At the time, Japan had announced their version of early access to the drug and most of the other participating authorities were about to begin their own reviews for making such a decision, with EMA issuing a recommendation to expand remdesivir compassionate use shortly thereafter.

Against this backdrop of robust collaboration, on June 18-19, the FDA hosted virtual bilateral meetings with the EC and EMA to review progress on ongoing activities and share horizon scanning across high-priority areas. For example, public and private sector entities are proactively exploring strategic partnerships to address the anticipated challenges related to manufacturing and rapid scale-up of potential COVID-19 vaccines or therapeutics. As two-prominent international regulatory bodies, the FDA and the EC/EMA can help inform global regulatory strategies to accelerate production and global access of products. In addition, the application of real-world data to understand the natural history of COVID-19, treatment patterns, and the performance of diagnostics is of keen interest for both the FDA and the EU.

The FDA and the EU are also promoting engagement with global regulators, under the International Coalition of Medicines Regulatory Authorities (ICMRA) forum, which is comprised of 28 regulatory authorities from around the globe. For example, in March, as vaccine candidates began to be identified, the FDA and the EMA jointly chaired the first global regulators meeting to discuss regulatory strategies to facilitate the development of SARS-CoV-2 vaccines. Subsequent ICMRA workshops that are focused on COVID-19 therapeutic development, observational studies, and real-world data as well as policy approaches are helping to support mutual awareness and consideration of potential guidance alignment. Such vigorous efforts are reflected in the ICMRA joint statement, which was issued in April 2020, with global regulatory authorities expressing their collective support in countering COVID-19.

To maintain strong oversight of foreign-manufactured medical products, the FDA is leveraging inspection reports completed by the EU and United Kingdom under the Pharmaceutical Annex to the US-EU Mutual Recognition Agreement (MRA). The MRA creates an environment in which FDA and the EU may rely on inspections performed by each others regulatory authorities to inform our regulatory decisions, such as drug approvals or addressing drug shortages.

We are also leveraging our international collaborations in our medical device work. The FDA and global partners (including the EC and other European partners) regularly exchange information on medical device safety issues and regulatory developments. These international relationships have never been more important as we work to maintain critical supplies of medical devices such as personal protective equipment, ventilators and ventilator accessories, as well as diagnostic testing supplies and test kits for COVID-19. Our interactions have included working through our embassies and European contacts to address supply chain disruptions, medical device shortages, and removal of fraudulent and poor-quality products from the market. Moving forward, shared learnings about antibody tests, otherwise known as serology tests their validation, results of ongoing epidemiological studies, and potential use in broader testing programs will inform our continued efforts to confront this pandemic.

Our work in these endeavors is, as always, rooted in the FDAs unwavering commitment to helping to foster the development of safe and effective medical products. We recognize the shared challenges of public health authorities across the world in fighting this pandemic as well as the tremendous opportunities to accelerate our mission critical work through robust scientific collaboration. We will continue to collaborate with our global regulatory counterparts as we seek to bring safe and effective COVID-19 vaccines and treatments to our citizens as quickly as possible and as part of advancing our vital mission to protect and promote public health.

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Partnering with the European Union and Global Regulators on COVID-19 - FDA.gov

June 24, 2020, 11:19 PM

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With the highest reported coronavirus case load, Americans will likely be barred from traveling to more than 30 European countries when the European Union moves to reopen its borders to outside travel next week.

The decision has been seen as a rebuke of how the Trump administration has handled the coronavirus pandemic, with the outbreak's spread surging to its highest level in two months, even as other countries start to reopen.

The EU's member states are actively debating a list of countries from which to allow tourism and business travel, a spokesperson for the European Union's mission in Washington told ABC News.

The list will be "based on objective criteria, the first among them being the epidemiological situation in a given country, which should be as good as or better than in the EU," the spokesperson said, without listing specific countries.

A man looks at mostly empty flight schedule screens in the Atlanta International Airport as the coronavirus outbreak continues in Atlanta, May 29, 2020.

That almost certainly means travel from the U.S., which has reported over 2.3 million cases as of Wednesday, will be banned, especially as certain parts of the country have seen dramatic rises in cases in recent days.

More than 15 million Americans usually travel to Europe each year, with Italy, France and Germany topping the list of countries most visited by Americans. All non-essential travel to Europe has been shut down since March.

The U.S. still bars any foreign citizen who has traveled in the prior two weeks in 28 European countries, Brazil and China. Those 28 European countries include the United Kingdom and Ireland, as well as the Schengen Area -- a group of 26 nations that have looser border restrictions between them, including France, Germany, Greece, Italy, Portugal and Spain.

Outbreaks in Russia, Brazil and India are also mushrooming, leaving those major countries likely barred by the EU as well, whose member states have largely contained the coronavirus' spread.

A passenger walks to Lufthansa check in counter at Frankfurt Airport during the novel coronavirus pandemic, June 15, 2020, in Frankfurt am Main, in Germany.

EU countries are set to reopen their borders to one another on July 1, with the list of permitted outside travelers updated "regularly ... to take into account the evolving health situation," according to the EU spokesperson.

Secretary of State Mike Pompeo said the U.S. and EU are working together "to make sure that we have all of the elements in place to reopen travel."

"It's important for the United States to get Europeans the capacity to travel back to the United States. It's important, very important for the Europeans to fully reconnect with the American economy as well," he told reporters, a nod to the desperation in some European countries for tourism to resume amid deepening economic pain.

"We certainly don't want to reopen in a way that jeopardizes the United States from people traveling here, and we certainly don't want to cause problems anyplace else," Pompeo added.

Excerpt from:
European Union likely to keep ban on Americans because of coronavirus fears as it reopens its borders - ABC News

Last year, flights across the Atlantic, to Europe and other destinations, accounted for about 17 percent of passenger revenue for United Airlines, or about $7.4 billion. Such flights generated about 15 percent of all passenger revenue for Delta, or $6.4 billion; and about 11 percent of passenger revenue, or $4.6 billion, for American Airlines. They were particularly important to United and Delta, generating a quarter of passenger profits last year, according to the Transportation Department.

Tens of millions of people flew between the United States and European Union countries in 2019. Many traveled for business to and from cities like New York, Los Angeles and San Francisco and Amsterdam, London, Paris and Frankfurt. Many others fanned out further to vacation, particularly in the summer when international flights are often nearly full as American families jet off to Italy and Greece, and Europeans check out New York and California.

Of course, travel between the United States and the European Union has been restricted since March, when governments on both sides of the Atlantic barred most visitors to prevent the spread of the coronavirus, with exceptions for repatriations and essential travel by medical professionals. At the time, the United States had just over 1,100 coronavirus cases as the virus spread extensively in Italy and Spain. Today, the United States leads the world with about 2.4 million cases, and infections are surging in Arizona, California, Florida, Texas and other states.

Because of the countrys size, the vast majority of tickets sold by U.S. airlines are for domestic travel. Those flights have led the industrys recovery, as Americans slowly start to visit friends and family and make limited vacation plans, a pattern unfolding in countries around the world. Higher-profit business and international travel are expected to follow far behind.

I think international travel is probably going to lag domestic by up to 12 months, Ed Bastian, Deltas chief executive, told shareholders on a call last week, citing travel bans around the world as one reason.

Read the rest here:
Europe Travel Ban on U.S. Visitors Would Be a Blow to Airlines - The New York Times

On the occasion of International day against drug abuse and illicit trafficking, the EMCDDA and Europol are joining representatives of the EU institutions today in providing the European perspective on the impact of COVID-19 on the world drug situation. The panel discussion will conclude a special event of the United Nations Commission on Narcotic Drugs (CND) and is co-sponsored by the European Union and the United Nations Office on Drugs and Crime (UNODC)(1).

In a statement marking the day, European Commissioner for Migration, Home Affairs and Citizenship Ylva Johansson said: The route from drug producer, to distributer, to user, and indeed to money launderer, is becoming ever more sophisticated, more circuitous and more profitable. In recent years, illicit drugs have increased in availability, with technology enabling online trade, postal dispatch, and hidden profits throughout the EU. Modern organised crime needs a modern organised response. We will soon present a robust and ambitious EU action on tackling drug smugglers, improving prevention strategies and targeting those who profit from others addiction'.

Floriana Sipala, Head of the Organised Crime and Drugs Policy Unit at the European Commission, will present the opening remarks on the CND panel, followed by a speech from Europol Executive Director Catherine De Bolle. EMCDDA Director Alexis Goosdeel will deliver the closing remarks (2).

The EMCDDA and Europol have been taking the pulse of the impact of COVID-19 on drug use, drug services and drug markets. In a report published last month (3), they explored drug market developments under the pandemic and their impact on public health and security in the EU. The analysis reported higher prices, local shortages and reduced purity for some drugs, while noting continued violence among suppliers and distributors. It also described how organised crime groups have remained active and resilient, by adapting transportation models, trafficking routes and concealment methods during the pandemic.

Speaking today, Catherine De Bolle said: The pandemic has had a major impact on our lives, and is slowing down our economy. Unfortunately, this downturn has not been seen in international drugs trafficking. While our legal economy is weakening, criminal markets have continued their business and have become even stronger, generating huge profits. The movement of bulk quantities of drugs to the European Union and between EU Member States has continued and seizures of illegal drugs in some EU countries during the first half of 2020 have been higher than in the same months of previous years.

More than ever, this worrying trend should motivate us to ensure that any recovery from the pandemic is accompanied by a strong and effective law enforcement response, combined with a sustained public health response. We need to collectively establish that drug traffickers do not benefit from the potential social and economic consequences of the crisis, Executive Director De Bolle added.

EMCDDA Director Alexis Goosdeel declared: The economic recession that we have in front of us is likely to be harmful in terms of mental and physical health and could result in a significant increase of substance use in the general population. It can be expected that it will amplify the negative consequences of the pandemic for people who are using drugs and for vulnerable groups in general. Therefore, it is of utmost importance to integrate drug-related services into the essential health services at national level, to provide adequate equipment and tools for frontline workers, and to maintain the funding and functioning of drug-related services in the post-pandemic period.

Alexis Goosdeel concluded: The way in which the different services and authorities have been working together in the European Union in the times of this pandemic has shown that the balanced approach of the EU drugs policy has contributed to care and to protect, rather than to punish.

Original post:
EMCDDA and Europol join EU institutions in dialogue on the impact of COVID-19 on the world drug situation - EU News

Boris Johnson appeared unwilling to compromise in order to secure a trade and security deal with Brussels when he joined EU leaders for a summit last week, one of the three who attended the meeting has told the Guardian.

David Sassoli, the president of the European parliament, punctured a recent outbreak of optimism over a potential deal by warning that the EU had been left concerned at the end of a video conference call by the lack of enthusiasm to find common ground on the most contentious issues.

After the discussions last Monday, the British prime minister insisted he could see no reason why an agreement could not be secured with Brussels by the end of July following intensified talks.

In a joint statement, Johnson, Sassoli and the presidents of the European commission and council, Ursula von der Leyen and Charles Michel, had said new momentum was required.

But in an interview with the Guardian, Sassoli warned that he had not been imbued with confidence the prime minister was ready to do what was necessary to secure agreement before the end of the transition period on 31 December.

Together, we are very worried because we dont see great enthusiasm from the British authorities and we dont see a strong will to get to an agreement that satisfies all parties, he said.

Obviously as an agreement, it has to satisfy both parties that it cannot advantage one over the other. And this puts us in a situation in which at the moment we are frankly a little bit worried.

The two sides are stuck on issues of access to British waters for European fishermen and dispute resolution in a future deal, as well as the so-called level playing field provisions, where the EU has been demanding common environmental, labour and social standards.

On Wednesday, Barnier reiterated that he was willing to work on clever compromises in the new rounds of talks scheduled in July and August, mentioning regulatory equivalence as an alternative to the UK incorporating EU state aid law into domestic legislation.

Sassoli said Barnier had been given the maximum margin of flexibility by the member states to find a compromise, but that it takes two to tango. There cannot be one party that prevails, Sassoli said.

Basically, the fact that they dont really want to build upon the political declaration, this really does disturb us greatly, because that has to be the basis for everything for the whole negotiation, Sassoli said, in reference to the 27-page document agreed last year on the scope of a future deal.

We reached an agreement, and it now must be respected. This really is something which concerns us at the moment.

The UK has taken a minimalist approach to the agreement in the political declaration to incorporate level playing field provisions in a treaty ensuring neither side is able to undercut the other by downgrading their standards. The UK negotiator, David Frost, has rejected any deal that sets up EU law as the common standard to meet.

Sassoli said that when the EU leaders emphasised during the meeting the need for a deal that would give the European fishing fleet fair access to UK waters, he was also concerned by the prime ministers reply.

The response that was given by the prime minister was that fishermen voted for Brexit. We want to respect their point of view, of course, but we also believe that were talking here about a very important resource both for the UK and for Europe, and were talking about the sea, so we think we can come to a common agreement on this.

The prime minister has said he will not extend the transition period, with the deadline for an agreement on extra time passing next week.

Sassoli said he had personally hoped that an extension would be sought given the difficulties in negotiating the terms of the future relationship during the coronavirus pandemic. Both Barnier and Frost have been infected with the virus during the crisis.

Sassoli, an Italian MEP since 2009, who was elected the president of the parliament last year, said he feared Downing Street was seeking to rush the EU into decisions by shortening the timeframe for talks.

He said: This [extension] is something that I actually hoped would happen for technical reasons, because we know that covid has cost us a lot of time in negotiation, so it could have been a very good opportunity. If this really is our goal, if we want an agreement and it would have given us a few more weeks

I do believe that it is a way to put the European Union in a difficult position, an unpleasant position, a position in which no one is is respecting the goodwill which was initially shown to go towards agreement.

Excerpt from:
EU parliament leader: Boris Johnson seems unwilling to find compromise in Brexit talks - The Guardian