What is the MAPS Act? A Guide to the Mapping America’s Pharmaceutical Supply Act

In a muddle over MAPS? Read our brief introduction to the pharma supply chain visibility legislation currently making its way through the US Senate.

Pressure for government action to bolster the resilience of pharma supply chains has been building in the US for some time.

Among Joe Biden’s first actions as US President, a little more than a month after coming to power in January 2021, was Executive Order 14017. It aimed to “strengthen the resilience of America’s supply chains”.

Pharmaceuticals were a key focus.

That led to the 100-day supply chain review in June that year and, subsequently, the Department of Health and Human Services (HHS) Essential Medicines Supply Chain and Manufacturing Resilience Assessment the following May.

Background – The Road to the First Pharma Supply Chain Bill

But while the executive continues to cajole the industry, other branches of government are pushing forward their plans. In the legislature, Michigan Senator Gary Peters has long taken an interest in pharma shortages and the supply chain issues that often underpin them.

In August 2019, as Ranking Member of the Senate Homeland Security and Governmental Affairs Committee, Peters wrote to the FDA expressing concern over ongoing drug shortages – at the time, the highest in almost five years.

“Drug shortages are creating devastating health and economic consequences for patients, hospitals, and consumers. For patients, the impact on care is significant, as shortages cause delays when receiving emergency medications, undergoing medical procedures, and obtaining needed prescription drugs,” he warned.

That led to a report later in the year on “skyrocketing prescription drug prices and drug shortages”. It noted many of the now familiar issues around drug supply chain resilience, such as the reliance on China and India for active pharmaceutical ingredients. Rising prices and the shortages that often prompted them weren’t just a public health issue, Peters maintained, but a “national security crisis”.

By this year, and in the aftermath of the pandemic, the senator’s focus on supply chain vulnerabilities had intensified. A new report in March showed that “[D]rug shortages, as well as a lack of transparency into our pharmaceutical supply chains, present an ongoing national security risk and have made it harder for health care professionals to treat patients.”

The report found that between 2021 and 2022, new drug shortages increased by nearly 30 per cent. It also found that over 90 per cent of generic injectable drugs used to treat serious injuries or illnesses in the US relied on critical materials from China and India, and nearly 90 per cent of generic API manufacturing sites were located overseas.

Supply Chain Visibility as a Critical Issue

According to the report, tackling vulnerabilities was complicated by a lack of visibility in the supply chain.

“Neither the federal government nor industry has end-to-end visibility of the pharmaceutical supply chain – from the key starting materials, APIs, finished dosage and various other manufacturers that are ‘upstream’ – to the ‘downstream’ suppliers, which include purchasers and providers. This lack of transparency limits the federal government’s ability to proactively identify and address drug shortages,” the report notes.

It continues: “Although some generic drugs appear to have multiple and diverse drug suppliers, they in fact may rely on the same API source or manufacturer. As a result, the universe of actual suppliers for a particular drug may be much smaller than it appears, increasing the risk of shortage if that API source or manufacturer withdraws supply. The FDA is currently unable to assess the percentage of life-supporting and life-sustaining medications that have fewer than three manufacturers or rely on only one API supplier because the FDA does not have a list of life-supporting and life-sustaining drugs.”

Following the report’s release, Peters convened a full Homeland Security and Governmental Affairs Committee hearing  to discuss its findings and recommendations.

“Drug shortages are not new. There are a number of factors that contribute to drug shortages, including economic drivers that lead to a lack of manufacturers willing to enter or remain in the market or invest in quality manufacturing systems, insufficient visibility into the entire supply chain for critical medications, and an overreliance on foreign and geographically concentrated sources for the materials needed to make these drugs,” Peters said at the opening of the hearing.

MAPS Introduced

All this led Peters and other senators to introduce two pieces of legislation to the Senate in July.

One, the Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act, introduced on July 26, 2023, aims to increase the supply of critical medications and mitigate “the national security threat posed by our nation’s overreliance on China for critical medications”.

It would do so by requiring the Department of Health and Human Services (HHS) to award contracts to “quality generic drug manufacturers” in the US or another OECD country to build and maintain reserves of critical drugs; oblige these contractors to keep sufficient reserves of key ingredients and finished drug products and production capacity to prevent potential shortages; and prioritise domestic producers for federal contracts.

The other, introduced just over a week before on July 18, with senators James Lankford and Mike Braun, was The Mapping America’s Pharmaceutical Supply (MAPS) Act – specifically aimed at boosting supply chain visibility as key to building resilience.

“As we saw firsthand during the COVID-19 pandemic, federal agencies did not have enough visibility into our reliance on foreign manufacturers and other chokepoints in the supply chain, limiting their ability to anticipate and respond to drug shortages and related challenges,” said Peters, introducing the bill. “This bipartisan legislation will provide the federal government with a more comprehensive understanding of the weaknesses in our pharmaceutical supply chains so we can take steps to address them and prevent future shortages.”

“This bill will shed light on the weaknesses in our pharmaceutical supply chains and allow us to make better informed decisions to address vulnerabilities in our drug supply chain,” added his cosponsor Senator Braun.

Mapping America’s Pharmaceutical Supply Act – Key Provisions

The bill consists of three key requirements:

It also requires the HSS to identify and regularly update a list of essential medicines, including both the drugs of their APIs.

These are defined as those likely to be required to respond to a public health emergency or chemical, biological, radiological, or nuclear threat and those for which a shortage would pose a significant risk to the US health system or at-risk populations.

The bill's text makes clear how ambitious this is, stating that the intention is to map “the entire United States pharmaceutical supply chain, from inception to distribution”.

That includes the location of API and finished dosage forms of the essential medicines, including “the amount of such ingredients and finished dosage forms produced at each such establishment” and establishments involved in producing the key starting materials and excipients needed to produce the APIs.

It also requires the HSS to keep a database of regulatory actions, including with respect to labelling requirements, registration and listing information, recalls, inclusion on current and prior drug shortage lists and discontinuances of the medicines.

A Joint Effort – Pharma Industry Responsibilities Under MAPS

The need for private sector involvement is clearly stated in the bill’s text.

First, right at the outset, the proposed legislation clarifies that the supply chain mapping by the HSS is to be done in coordination with other relevant agencies, such as the Secretary of Defense and the Secretary of Homeland Security, “including through public-private partnerships”.

Second, the list of essential medicines is also to be drawn up (and maintained) “in coordination with the private sector”.

Moreover, where obligations on the industry are not explicitly set out in the text, they are heavily implied. Without massive industry input, it is impossible to see how the HSS could map the “entire” supply chain – from inception to distribution.

Should it try, its efforts are unlikely to be the last word: The bill provides that within 18 months of its enactment, the HSS must report on “gaps in data needed for full implementation”.

Next Steps for the MAPS Act

The Act has already received significant bipartisan support inside the Senate and from outside organisations, such as the American Society of Health-System Pharmacists (ASHP), the American Society of Clinical Oncology, the American Hospital Association (AHA), United States Pharmacopeia (USP).

In a virtual summit in September on Drug Shortages co-hosted by USP, Peters reiterated his call to push through legislation: “We must urgently put these solutions in place to ensure that everyone can access the lifesaving medications that they need,” Peters told summit attendees.

While MAPS is not yet law, previous efforts will give supporters cause for optimism: In June, the President signed three bipartisan bills authored by Peters to bolster cybersecurity, including the Supply Chain Security Training Act.

His bill to strengthen US supply chains and domestic production capacity in relation to homeland security has also passed the committee stage.

It may be some time before MAPS is signed into law – or perhaps it will be usurped by legislation originating elsewhere. However, as we’ve said before, change is coming. The proposed legislation vindicates what we’ve long argued: That supply chain resilience begins with supply chain visibility.

Pharmaceutical supply chain risk management software such as SCAIR® is specifically designed to address the issues highlighted by the Senate report that helped prompt the legislation, such as the concentration of risk through reliance on common API or manufacturing sources. As it noted, the “universe of actual suppliers for a particular drug may be much smaller than it appears”. SCAIR® is the x-ray vision that reveals these hidden vulnerabilities.

Likewise, the Act is right to focus on identifying critical drugs and points of vulnerability – not relying on the impossible task of identifying all the potential sources of disruption. Again, this is the approach we’ve long taken with SCAIR® – helping focus on impacts, not causes.  

We’ve long believed this is the best route to supply chain resilience. Increasingly, it seems likely to be the approach governments will insist the industry takes to ensure the supply of critical drugs is maintained.

Acting now, using tools such as SCAIR® to gain visibility – and sharing it as required – will enable pharma businesses to ensure the relevant authorities see them as allies rather than obstacles in that effort.

Regulatory Risks for Pharma in Brexit Uncertainty

The Regulatory Impact of No-Deal Brexit on the Pharmaceutical Sector

In the first of a new series of industry insight articles, Intersys Risk Ltd Director Catherine Geyman, examines the various legal risks to the pharma sector posed by a no-deal Brexit.

Importers, distributors, pharmacists and others face a fast-changing legal environment in the event of no-deal

 With Boris Johnson taking the keys to number 10, the prospect of a no-deal Brexit looms large. It is “do or die” when it comes to departing in October, he says, and the risk is probably at its highest since March, before Theresa May first confirmed she would ask for an extension to our departure date.

With that realisation, many of the now well-worn discussions about the risks of disruption to the pharma supply chain are resurfacing. But, as the chances of leaving the EU without a deal grow, new risks are also coming into focus – not least the legal framework in which drug companies operate.

Looming liability for pharma distribution

medical warehouse worker man loading boxes with medcine drugs by hand forklift

Of course, it’s long been recognised that the regulatory framework for the UK industry is heavily reliant on more than four decade’s worth of acquis communautaire. As we’ve looked at before, that change will manifest itself physically, with the European Medicines Agency in London relocating to Amsterdam, as the UK ceases to be a member.

More recently, however, we’ve also had some indications of what that may mean in practice – and the changes are far from being simply symbolic.

As this piece by a product liability expert makes clear, for example, it threatens serious consequences for those importing drugs. Distributors importing products (including pharmaceuticals) from the EU and selling them to retailers currently benefit from a level of protection against liability for personal injury due to a product defect: Provided they have conducted due diligence on the supplier and its product, they won’t be held at fault. Rather, it’s likely to be the manufacturer that bears the cost; and within the EU consumers can seek compensation from the manufacturer even where they’re in another country.

That changes if we leave the EU without a deal, however, as the expert explains: “As an importer into the UK, the distributor will be liable to the injured person as if he were the manufacturer.”

Moreover, for injured parties, making a claim against the EU-based manufacturer is likely to become much more complex, and much less likely to succeed after Brexit. This will make the UK importer the more viable and likely target for any consumer seeking compensation.

That’s a significant change, and one for which there’s been little discussion or debate, and for which there is likely to be widespread ignorance in the sector. The advice for importers is relatively simple: “[They] should review their product liability insurance,” writes the expert.

It is, though, just another overhead already hard-pressed businesses will not relish having to take on board.

Serious Shortage Protocols

Female pharmacist sat at desk writing notes with medicine boxes in background.

It’s far from the only change the pharma supply chain faces, either.

 This month, for instance, Amendments to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 made in June came into effect. These introduce Serious Shortage Protocols (SSPs) into the terms of service for NHS community pharmacies. As the Pharmaceutical Services Negotiating Committee explains, if an SSP is put in place for a product, a retail pharmacy business or a dispensing appliance contractor must consider supplying in accordance with the SSP rather than fulfilling an NHS prescription for that product.

In practice, this means that, to protect supplies of a drug where shortages are an issue, the pharmacy can use the relevant SSP when fulfilling a prescription to dispense less of the drug, give a different strength, or provide an alternative product. Use or otherwise of SSPs could therefore have significant impacts for the supply chain of not only the product for which the SSP applies but also, depending on the terms of the protocol, likely alternatives that the pharmacists may choose.

On the one hand, this provides additional flexibility in the supply chain and should help minimise disruption. On the other, though, the impact is going to be difficult to predict – not least because pharmacists still have discretion as to whether to use the SSP. They only have an obligation to consider it, and if they consider supplying a different product or quantity is unreasonable or inappropriate, they can choose to fulfil the prescription as written.

Preparing for anything

pharmaceutical logistician using internet of things solution based on blockchain technology to secure data integrity of drug supply chain. Networking concept for distributed ledgers.

In fact, every part of the supply chain is likely to be affected by the legal changes Brexit will bring. In June the government published guidance on the “written confirmation” that will be required for each shipment of Active Substances manufactured in the UK exported to the European Economic Area in the event of a no-deal exit; and that followed guidance on how to apply for a certificate of pharmaceutical product.

Regulatory resources

All this preparation is encouraging – even if it means there’s a lot to take in and there are resources that can help pharma businesses keep abreast. TOPRA’s site for professionals in healthcare is one useful site, while, in April, the House of Commons library published an overview of the current state of regulations relating to medicines, and how that might change. But one line from the introduction to the that briefing jumps out:

“It is still not known how medicines will be regulated when the UK leaves the EU.”

Unfortunately, three years on from the vote to leave the EU and – possibly just three months before we actually do – that remains true. All pharma businesses across the supply chain can do is, first, keep a watchful eye out for regulatory developments as they become clear; and, second, keep their supply chain risks under constant review as the legal landscape continues to change around them.

Head shot of Catherine Geyman, Director, Intersys Risk Ltd

Catherine Geyman, Director, Intersys Risk Ltd

Puerto Rico is hit again

The thing about the hurricane season is it’s always easy to speak too soo.

We noted a couple of weeks ago that Puerto Rico, a key production centre for pharma manufacturers, had escaped the worst of hurricane Irma.

Yet the clean up wasn’t even finished when the island was hit by the worst storm in 80 years, Maria, bringing “total devastation”. A number of factors have left the island particularly hard hit: Already fragile infrastructure leaving most without electricity – for weeks and many possibly for months; even cell phone coverage is limited; and widespread flooding has been exacerbated by the failure of the Guajataca Dam. The island also already filed for bankruptcy earlier this year, leaving it poorly prepared to tackle the costs of getting back on its feet.

Hurricane Maria might also have proved that it was a bit early to congratulate the industry and governments for avoiding drug shortages following Irma and Harvey. On Monday, the FDA warned that shortages could occur if the Puerto Rico pharma industry wasn't helped to get up and running quickly.

“The island is home to a substantial base of manufacturing for critical medical products that supply the entire world. This industrial base is an important source of jobs and economic vitality for the island. It is a key to Puerto Rico’s economic recovery. The manufacturing facilities are also a pivotal source of critical medical products for the entire United States,” its statement read.

The problem, as ever, is both the scale of the storm – a “catastrophic event unlike many the United States has faced”, as the FDA put it – but also the scale of pharma manufacturing in Puerto Rico. That’s shown in a map taken from the tool in our SCAIRTM software of FDA Registered Drug Establishments affected:

With such a concentration in an area so prone to tragedy, the challenge for the industry to maintain supplies will alway be substantial.

Time to get serious on supply chain cyber risks

The new Cyber Highway service makes it easier than ever for businesses to start to asses the cyber security of their suppliers. It’s an opportunity more need to take.

Cyber is rising up the supply chain. Last month former Home Secretary David Blunkett launched the Cyber Highway, a new website through which business can check whether suppliers are certified under the Cyber Essentials scheme.

The scheme promotes basic standards of “cyber hygiene” to protect against common risks such as hackers and malware infections. Businesses can have a self-assessment questionnaire independently reviewed by an external certifying body to gain a Cyber Essentials badge or have an external body actually do the tests for a Cyber Essentials Plus badge.

For central government, all contracts handling personal information or providing certain ICT products and services have required certification with the standard since October 2014. Two years on, the new Cyber Highway site makes it easy for private sector businesses to effectively apply the same standard. They can now track suppliers' progress towards Cyber Essentials certification in real-time.

It’s hoped this will, in turn, prompt more businesses to sign up to the scheme and work to achieve certification – vital following the vote for Brexit, according to Blunkett.

“It is more important than ever, post-Brexit, for businesses to hold an internationally-accepted certification, as competition increases and an extra level of cyber-resilience is required,” he said at the launch.

Opens doors: Risks from suppliers, vendors and customers

There’s also a couple of other reasons to welcome such moves.

One is that many big security breaches can be traced back to attackers exploiting vulnerabilities of suppliers.

That might mean criminals targeting businesses’ raw materials suppliers or just service providers. The data breach at US retailer Target, which in 2013 had 40 million customer details stolen and leaked, remains perhaps the prime example of the latter. That attack was the result of network credentials stolen from its refrigeration, heating and air-conditioning subcontractor.

The second reason to welcome initiatives like the Cyber Highway is related to this: Many businesses still seem to be complacent about this aspect of their supply chain risk.

A recent survey by insurance brokers Marsh found that only a quarter of UK large and medium-sized corporations assess their supply chains for cyber risks. As the report notes: “[T]he overwhelming majority of companies are leaving themselves exposed to third parties, from service providers to customers.”

Anything that gives businesses the tools to start changing this can only be a move in the right direction.

Who uses SCAIR, our Risk Management Software?

SCAIR, our award winning Supply Chain Risk Management software is in use by a number of global organisations who understand the criticality of their supply chains and want to protect themselves against their disruption.

Contact us to discuss how SCAIR can help you improve your supply chain resilience.

Supply Chain backup plans, weak links and Acts Of God.

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