Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The long and winding road for the FDA’s user fee bill may finally be reaching its destination on Capitol Hill. In a rare display of bipartisanship, the smart money is on the bill being sent to the full House of Representatives next month after more than a year of twists and turns.

The good new for medical device firms: It appears an amendment that would let the FDA nix applications based on similarity to recalled, defective medical devices won’t be in the final bill. That’s a disappointment to some consumer groups, and the amendment’s sponsor, Rep. Ed Markey, Democrat from Massachusetts.

Looming over the bill and healthcare-land in general is an expected June Supreme Court ruling on President Obama’s national healthcare program.  However that ruling goes, it could re-politicize the healthcare debate and knock the FDA user fee bill off the tracks unless it gets passed before the ruling.

The bill as currently written would let the FDA collect user fees from device, pharmaceutical, and biologics manufacturers to help fund the agency’s approval and monitoring work.

The Senate is expected to take up its own, similar, version of the bill next week.

Based on the relatively smooth mark-up, or review, of the bill, most insiders expect it to emerge in pretty much its current form and become the law of the land quite soon.

Watch this space in the coming weeks and months. We’ve had a bit of a respite from partisanship, but it’s election season in D.C. and anyone who expects this relative harmony to continue is as naive as a Washington Redskins fan expecting the team to win a Super Bowl anytime soon.

Russ King, President, Methodsense

In part one of this blog, we discussed some common misconceptions about Cloud computing for life sciences companies. We also talked about some of its benefits. This time around we’re going to look at  a few more misconceptions and highlight some of the ways it can help life science companies get a better handle on edata.

Misconception #6: Maintaining your Cloud in a Validated State is Impossible

As long as you’ve understood the impact the provider’s systems and infrastructure have on your validation strategy, then you can create controls to ensure your private cloud remains in a validated state.   Anticipate the need to collaborate with the cloud provider on change controls with the introduction of hardware or software modifications.  Again, you can set these expectations, and probably garner more cooperation, if you incorporate such considerations into your vendor selection criteria.

Misconception #7: A Cloud Environment does not Allow the Segregation of Information

As mentioned in Misconception #1, there are a variety of cloud environments. Private clouds are the best solution to manage data in regulated industries. They give you the most control and security because you can limit who has access to your computing environment.

With a private cloud you’re also able to set up different channels for each information group and create boundaries with respect to your regulated information. These channels allow you to “segregate” your data, establish controls and set permissions.  Virtual machines can also serve a similar purpose.

Misconception #8: FDA Regulations Related to Validation do not Apply to Clouds

A third party hosted cloud environment does not excuse you from regulatory obligations that would otherwise exist if you were hosting the services inside your company.   The same goals and strategies you apply to your local infrastructure should be applied to your cloud environment. FDA regulations can be met; you just have to be aware of the applicable risks, the controls for mitigating those risks and the right partner to assist you.

Summary

When you’re in the process of developing your Life Science cloud environment, a detailed risk assessment will be critical to your success and security. Your risk management plan should:

• Include a complete vendor audit
• Outline the operational processes and procedures of the cloud environment
• Identify any major security and privacy risks
• Consider business, financial, compliance and intellectual property risks
• Document risk management strategies
• Provide recommendations to improve the security and on-going compliance

Conclusion

Because you are ultimately responsible for your data’s authenticity, veracity, and security, establishing compliance boundaries and conducting periodic analysis of the technology environment is imperative. Be sure to define your validation and regulatory requirements so they apply to your cloud solution.

Whether you are an early adopter or are fighting virtualization every step of the way, cloud computing is here to stay. Shifting your technology operation to the cloud includes benefits, such as:

• Improved scalability, both up and down
• Increased access to and utilization of key business assets
• Improved controls on security and data access
• Increased innovation due to collaboration and availability of resources

Although cloud computing isn’t without it’s difficulties, it’s definitely a viable option for Life Science businesses. To ensure a successful implementation:

• Perform a complete vendor audit
• Outline the operational processes and procedures of your cloud environment
• Identify any major security and privacy risks
• Consider business, financial, compliance and intellectual property risks
• Document risk management strategies
• Provide recommendations to improve the security and on-going compliance

If you missed Part I of this series, you can read it here.

About the author:

Russ King is President of Methodsense, a consulting firm that helps clients deliver medical and technological breakthroughs by effectively meeting the requirements needed to bring their products to market.  They guide medical device, biotech and pharmaceutical companies with quality, regulatory and technology solutions, enabling clients to operate more effectively during the commercialization process and beyond. MethodSense is located in the heart of Research Triangle Park, North Carolina – home to one of the world’s largest biotechnology clusters and a hub for technology-based innovation.  We invite your communication: Russ King, (919) 313-3962 or rking@methodsense.com.

Russ King, President, Methodsense

In the first part of this blog, we’ll examine the advantages life sciences companies can enjoy by better understanding and leveraging Cloud computing.

Advantages of the Cloud for Life Science Companies

Cloud computing and virtualization is an evolving paradigm that is transforming the way we do business. The economy of scale the cloud provides reduces costs and increases operational efficiencies that reap major benefits. This operational shift can be intimidating for Life Science companies; however, there are significant advantages for moving to the cloud.

Some examples include:

• Maintains compliance across multiple applications more efficiently
• Scales up and down with ease
• Provides a platform for collaboration and resource pooling
• Unifies your infrastructure for end users
• Increases the control, availability and flexibility of your data center
• Reduces computing maintenance costs and, depending on the model, can reduce hardware costs

While these advantages are enticing, it’s critical that Life Science companies understand some common misconceptions of the cloud before adopting it as a new technology strategy.

A word of advice: The challenges of implementing cloud computing for life science companies have been highlighted by recent publications from IEEE, CIO Magazine and others by observing the absence of accepted standards for the cloud.  Before delving into cloud computing for your Life Science company, be certain you have the proper skills on hand to help you.  Missteps and short cuts in the path to regulatory compliance typically create additional and unnecessary expenses down the road.

Misconception #1: All Cloud Environments are the Same

According to the National Institute of Standards and Technology (NIST), there are actually four types of clouds, and each is intended for different uses.

Private: This infrastructure is for exclusive use by a single organization. It is only used by its owners, making it the most secure environment. It may be owned, managed, and operated by the hosting organization, a third party, or a combination of them, and it may exist on or off premises.

Community: This system is for exclusive use by a specific community of users from organizations that have shared concerns (e.g., mission, security requirements, policy, and compliance considerations). It may be owned, managed, and operated by one or more of the organizations in the community, a third party, or a combination of them, and it may exist on or off premises.

Public or Vendor: This infrastructure is for open use by the general public. They are shared among multiple subscribers. It may be owned, managed, and operated by a business, academic, or government organization, or some combination of them. It exists on the premises of the cloud provider. Because of the nature of public clouds, this architecture may present security, privacy and auditing issues.

Hybrid: This cloud type is a composition of two or more distinct infrastructures (private, community, or public) that remain unique entities, but are connected by standardized or proprietary technology that enables data and application portability (e.g., cloud bursting for load balancing between clouds). Hybrids can be used in the Life Sciences when a combination of regulated and non-regulated information is shared.

As a general rule, a private cloud can be effectively adapted to satisfy the stringent compliance needs of a Life Science company.

Misconception #2: Private Virtual Cloud Configurations are Proprietary to the Data Center

We frequently hear cloud providers talk about proprietary configurations or operational trade secrets.  Without debating the veracity of such claims, it is important to find and work with a vendor who can share, and work with you, when you are evaluating your cloud options. When a provider understands your needs and why your controls are important, we have found most providers are more relaxed about their “trade secrets” in favor of winning your business. Privacy, security and other controls should be collaboratively implemented with your provider so you can remain compliant. Carefully plan the security and privacy aspects of your cloud environment in partnership with your provider before implementing your solution.

Misconception #3: A Data Center’s SAS 70 Type II Certification can Replace an Onsite Audit

The proliferation of professional hosting companies, and subsequently the cloud computing services they provide, has created a competitive environment where service quality can be a competitive advantage.  Many hosting companies seek a SAS 70 Type II Certification to demonstrate their quality.

However, the audits performed in pursuit of SAS 70 Type II Certification are paid for by the vendor, constitute a snapshot of the vendor which may not be relevant to the timing of your contract with the vendor, and the audit may not sufficiently cover your Life Science regulatory concerns.  For the criticality of your business, you should sponsor the audit, ensuring you’ve adequately fulfilled your regulatory requirements.  Be prepared, however, to massage and coax the understanding of the vendor for cooperation before and during the audit. In our experience, most cloud providers focus on the acquisition of Life Science clients with little to no understanding of the regulatory environment we operate in.

Misconception #4: A Cloud cannot be Managed as an Autonomous, Independent System

Your cloud environment can be affected by the configuration and set up of other systems. There are other factors within the data center that may influence your operation: a vendor’s performance, upgrades to a vendor’s system and overall testing of general “cloud” components. In essence, your cloud consists of your vendor’s hardware, firewalls, raw data storage, networks and supporting applications. Even though you may use a private cloud, that network is still dependent upon the vendor’s underlying systems.

You must understand the total environment of your provider to ensure your cloud is secure and will remain secure if they make changes to it. The best way to proactively implement your cloud solution for long-term success is to perform a thorough risk assessment at the onset of your transition. A proper risk assessment will lead to identifying the controls that will secure your network regardless of your vendor’s behind-the-scene activities.

Misconception #5: The Data Center’s Procedures are Enough

While many data centers take the initiative to implement quality systems, SOPs and other quality measures, that doesn’t guarantee they will meet your quality management system expectations. Your cloud provider may need to make existing processes and procedures more robust and in a way that is more collaborative than they originally intended.  This kind of flexibility should be incorporated into your vendor selection criteria.

In Part Two of this blog, we’ll examine a few more important Cloud misconceptions, and offer some final thoughts on how life sciences companies can benefit fully from it.

Russ King is President of MethodSense, Inc.

Patrick Stone, President, TradeStone QA

Not many people are likely to sit down at their favorite restaurant and ask if the antibiotics are good today. But we can’t always assume we know what’s in our food. To help us feel a little better, the FDA last month took steps to help reduce the use of antibacterial substances in feedlot animals.

These steps include:

1. A final guidance for industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.
2. A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control, and treatment uses; and changing the marketing status to include veterinary oversight.
3. A draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.

The CDC and many local health organization have released numerous statistics on human deaths related to antimicrobial drug resistant bacterial strains which are staggering. Can the food industry help prevent the process of selecting for a super-strain bacteria?

The FDA has previously provided comments and testimony on the use of antibiotics by physicians and health care organizations.These education efforts promote patient education and proper use of a prescribed drug product. The idea is to limit the selection of drug resistant strains of bacteria.

The global health focus will continue to be in the fight against bacterial and viral infections. We must limit practices that select for these super-strain bugs and find innovative ways to limit bacterial infection.  Sprout and other vegetable producers have also used antibacterial substances in their farming practices. The resulting food borne outbreaks have resulted in super-strain bacteria related deaths and hospitalization.

We must all be aware of the impact in our food choices and sustainable food production methods.  Make sure to read your labels and support your local farms. Visit your farmer’s market and ask questions about their farming practices.  Your grocery store list will dictate what the grocery store will provide. We are responsible for helping reduce antibacterial resistant superbugs through our food choices.

Remember, you are what you eat! Know thyself!

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Sure, the Italians have better food the English richer royal culture and accents  and French women don’t get fat but we in America regulate medical devices better, don’t we?

Not so fast, says the EU.

They apparently aren’t happy that the FDA is writing internal reports and making public remarks saying medical devices, especially high-risk ones, aren’t regulated so well in Europe, according to an internal report quoted in the St. Paul Tribune.

British attorney Paul Ranson told us in that accent that the EU generally thinks it is already doing a nice job regulating medical devices, thank you very much.

“Not in a self-congratulatory way, but I think the sense in the EU is that they are doing it very well,” Ranson told us. And while it’s not the British way to brag, he also allowed that the EU is working on revising its medical device regulations now in an attempt to improve harmonization and centralization, among other issues.

But he called these changes — expected to be unveiled this Summer — to be more like “tweaks and not revolutionary” changes.

“The intention behind the revisions is to improve and strengthen the Directives and to meet growing expectations of European citizens,” Ranson said.

Paul Ranson

“The current Directives do not offer an uniform level of protection of public health in the European Union and new and emerging technologies have challenged the current Directives,” he added.  “In addition, the revisions aim to simplify the Directives delivering a transparent system whereby citizens can be confident in the safety of medical devices.”

As noted in the RAPS piece, EU officials have fired back at FDA personnel who’ve disparaged their regulatory regime.

As we and others have written elsewhere, many in the medical device industry wish the FDA would take some pages from the EU’s regulatory book. Or put another way, the medical device industry wishes the FDA would cut out a lot of the pages in its long regulatory book and adapt more to the relatively streamlined approach in the EU.

I don’t care what anyone says, I’m going to have some Freedom Fries for lunch tomorrow and wash it down with some sparkling San Pelligrino water while reading my favorite Graham Greene novel.

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the FDA’s attempt to “force its own agenda” over dissenting science or how its own advisory boards vote on regarding medical device classification is just part of a broader “systemic” problem with some at the agency.

As reported earlier in Medical Device Daily and elsewhere, an FDA advisory committee hearing in February for cranial electrotherapy stimulator (CES) medical devices was flawed, in part FWL alleges, the FDA violated its own rules in running the hearing.  FWL filed a March 9 citizens petition challenging FDA’s proposed classification of CES devices as high-risk or class III devices.

FWL VP Kelly Roman said he’s “heartened,” however, that the FDA has said publicly that it will discuss the situation directly with FWL.  “The fact that they responded at all” is unusual for the agency in a case like this, and Roman believes it bodes well for their desire to have their CES keep its class I designation.

But CEO Fisher worries that this kind of FDA activity is stifling medical innovation, especially for smaller companies who may not be able to afford a long and drawn out battle like this with the agency.

“I think there’s a growing culture of anti-industry” at the FDA, Fisher told us April 10. Specifically, he criticized a faction at FDA for “picking apart” and using aspects of research to prove it point it wanted to prove, but not always considering the full body of research that might support another position.

Roman doesn’t expect to hear from the FDA for many months, and has gotten no official timetable for the agency. “We appreciate that the FDA is a big slow moving ship,” he noted.

For a glimpse at some of the February hearing that troubled FWL click here.

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

If William Shakespeare was an FDA beat reporter, this is about the time he’d pull out his once more unto the breach bit as we dive back into the controversy regarding whether the agency is slowing the medical device approval process.

A new bi-partisan report from GAO praises the FDA for trying to fix this, then basically notes they haven’t actually fixed it. After reading the report, we could forgive Commissioner Margaret Hamburg if she felt beleaguered liked Shakespeare’s Henry V.

We’ve written about this back and forth he said/she said battle for many moons now and it boils down to this: The medical device industry says FDA is too cumbersome and slow and that it is thwarting innovation. FDA says it is doing better than it gets credit for and slams some device industry studies backing its position as flawed and misleading.

Well, both sides will have some additional ammo from this new GAO report, but overall I think it does more to bolster the medical device industry contention that reviews have gotten slower. GAO doesn’t blast anyone, and it takes great pains to put its findings into useful context. That’s something FDA and the medical device industry don’t always do so well.

“Even though FDA met all medical device performance goals for 510(k)s, the elapsed time from submission to final decision has increased substantially in recent years,” GAO notes. Despite making some progress in its approach, FDA’s bottom-line results are not so hot: “Specifically, from FY 2005 through FY 2010, the average time to final decision for 510(k)s increased 61 percent, from 100 days to 161 days.”

GAO also takes FDA to task for being “inconsistent” in meeting performance goals for PMA submissions. “While FDA met the performance goals for original PMA submission for four out of seven years the goals were in place, it met those goals for expedited PMA submissions only twice out of seven years.” Again, the bottom-line results aren’t a report card you’d want to bring home to Mom: “The average time to final decision for original PMAs increased from 462 days for GY 2003 to 627 days for FY 2008,” which is the most recent year for which data is available. Trends in 2009 and beyond don’t appear to be getting any better.

GAO sounded out industry trade and consumer groups and took away four big complaints:

• Insufficient communication between FDA and stakeholders throughout the review process.
• Lack of predictability and consistency in reviews.
• Increased time to reach final decision.
• Inadequate assurance of the safety and effectiveness of approved or cleared devices.

“FDA is taking steps that may address many of these issues,” GAO adds hopefully.

I wonder what Shakespeare would make of all this. Henry V died on the battlefield fighting his version of the good fight. No one is asking for that level of sacrifice from the FDA. But the agency should heed this GAO report and take a cool, hard look at how it reviews medical devices. Public safety is the top goal, of course, but sometimes that means encouraging innovation, too.

Vice President, Energy & Utilities Compliance, AssurX Inc.

FERC’s Order accepting with conditions (issued on March 15, 2012) regarding the ERO’s petition for approval of the “Find, Fix, Track and Report” (FFT) initiative was another positive step forward for electric reliability, NERC, Regional Entities (REs), and the registered entities.

The FFT process changes and improves the way REs and NERC address “Possible Violations.”  As a reminder, the petition proposes three tracks to address possible violations that are submitted to the REs and NERC:

1. A Notice of Penalty (in “Full” or “Spreadsheet” format)
2. An FFT informational filing; or
3. A dismissal

If the possible violation is determined to pose a “Lesser Risk” to the Bulk-Power System and meets certain qualifications, the possible violation may be addressed through an FFT informational filing.  These FFT informational filings would not be subject to a penalty, but would count as part of the registered entity’s compliance history.

NERC explains in their petition that the FFT process will promote reliability excellence by ensuring issues are mitigated and corrected. Also it will allow greater resources and attention be devoted to matters that pose a more serious threat to reliability of the Bulk-Power System.

This blog highlights why this is such a positive step forward for the industry.  There has been much discussion over the last few years about the importance of registered entities self-identifying reliability issues, developing an internal culture of compliance/reliability, and to mitigate self-identified issues.  NERC and REs track the issues the registered entities have self-reported.  NERC states that 70% of all identified compliance issues are self-identified by the registered entities.  The other 30% are discovered through the ERO’s CMEP.

With approximately 200 new possible violations being reported to the ERO each month, resources from all entities must focus on what will most impact reliability to the Bulk-Power System.  The REs and NERC have discussed the FFT initiative in workshops, webinars, and Trade Association meetings over the last 18 months.

How does a registered entity ensure that they will continually improve their internal compliance program?

The industry must embrace building a Corrective Action Program that is accepted by all employees and vendors.  The registered entities spend time training and familiarizing employees with the NERC 693 and CIP standards.  There must be a mechanism to identify possible violations and/or near misses.  The nuclear and life science industries have been doing this for decades.  It will take time for transmission and generation owners and operators, load-serving and distribution entities to develop their internal compliance processes.

AssurX has been working with clients for close to 20 years building “Corrective and Preventive Action (CAPA)” processes.  These companies know that by quickly identifying an issue and with proper disposition it will not only improve their compliance program, but also improve their overall business.

Corrective and Preventive Action (CAPA) Process Flows

For the FFT to be successful, the registered entities must demonstrate that they have addressed the underlying possible violation, describe any corrected actions and maintain evidence of such corrective actions.  This will all need to be available for verification by the ERO through audits, spot checks, random sampling or other inquires that might be identified later.

A corrective action tracking software program has been used by regulated industries for many years.  Audit history and archived records with employee names and date stamps are what the regulators will be looking for in the future.

The FFT initiative will be maturing over the next year, but this is an excellent step forward.  I will be writing future blogs discussing developments of the FFT process and what it takes to develop a strong CAPA program.  Some of the topics that will be discussed in building a CAPA program:

• CAPA Initiation
• Internal Investigation/Root Cause Analysis
• Action Planning
• Mitigation and Tracking
• Auto-Escalation, Notification and Reminders
• Effectiveness Verification
• Oversight

If you are interested in learning more about the AssurX compliance program and implementation of CAPA, please do not hesitate to contact us.

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Predicting things on Capitol Hill is never easy, especially as the election campaign “silly season” enters the picture, but it’s beginning to look like medical device companies should expect heavier regulation in 2012 – and that will only increase if President Obama is reelected in November.

The climate is not great for medical device firms, who are always one recall away from increased scrutiny. Add to that a recent poll from Consumer Reports that says the public wants more medical device regulation and less risk.

The poll was released just as House and Senate Committees have issued draft legislation to reauthorize the statute governing medical devices and at a time when the FDA’s process for reviewing new implants has come under intense criticism.

The House Energy and Commerce Health Subcommittee’s draft bill would significantly weaken device safety oversight and should be rejected by Congress, according to Consumers Union, the policy and advocacy arm of Consumer Reports. While the Senate Health, Education, Labor and Pensions Committee’s draft bill provides some additional protections for patients once devices are on the market, it misses the opportunity to enact a clear process for preventing unsafe devices from being sold in the first place, the consumer group claims.

“Recent problems with metal hip implants and surgical mesh have shown how our current system fails to ensure medical devices are safe and effective,” said Lisa Swirsky, senior policy analyst for Consumers Union. “Unfortunately, the House bill weakens current standards to speed up device approvals rather than improving safety oversight. The Senate bill offers some improvements but it should be strengthened to require stricter safety testing of new implants and life sustaining devices. Congress should recognize that the public is far more concerned about making sure devices are safe and work than how quickly they are made available.”

Consumers Union says the medical device industry has been pushing Congress to scale back oversight of implants and other devices, which it claims is necessary to promote innovation and make it easier to get new devices approved. But according to the new Consumer Reports poll, 82 percent of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.

In his FDA Matters blog Steven Grossman advises us not to take our eyes off the User Fee Authorization Process in 2012, which must be renewed by Sept 30.

Grossman sees three levels to watch: “ the MDUFA reauthorization itself including FDA-industry agreement on goals for the review process; a core of changes to the medical device review process that have consensus support, but not necessarily agreed-upon legislative language; and a group of more far-reaching changes to the medical device review process that are considered controversial.”

“There will be continued efforts to rollback or repeal the device tax imposed by the health reform act,” he also tells us.

Watch this space for more updates as the silly season gears up.

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

It sounds like the FDA is going to be one of relative winners on Capitol Hill when it comes to budget requests for Fiscal Year 2012. While many government agencies are under pressure to scale back, even the Department of Defense is in saving mode and poor NASA has just about given up on getting us to Mars anytime soon, folks we’ve talked to expect the FDA to get pretty close to its modest increase request.

That’s good news in many ways, perhaps even for those who don’t like the FDA having too active role in their lives (hello Medical Device companies).

The reason: Congress and others have “been asking the FDA to do a heck of a lot of stuff without a heck of a lot of money,” notes industry expert Mark Mansour, a partner at AkinGump and fellow AssurX blogger.

Mansour’s logic, and I’ve heard this now elsewhere, is that a better funded FDA will do a better and more consistent job when it comes to regulating food, drugs and medical devices. Much of the complaints I hear about dealing with the FDA, especially from device companies, is that they never know what to expect from one inspector to the next. Or even that FDA focus can change mid-inspection either because an inspector has left or something else changed at the FDA’s end.

In addition, the FDA is getting pressure from folks on Capitol Hill who believe medical device innovation in particular is moving to more friendly regulatory climates such as Europe. “Medical device investors feel they can get a more predictable approval process over there,” Mansour adds.

FDA is also struggling to replace outgoing senior inspectors and other knowledgeable personnel. It takes years for a new FDA inspector to come up to speed. Think baseball where even a phenom like Washington National Bryce Harper isn’t an instant major leaguer, rather than say football where a top draft pick can be an immediate star in the pro’s, which is what the Washington Redskins are banking on with Robert Griffin.

It may be hard for medical device manufacturers and others to hear, but giving the FDA more budget might be good news for everyone.

More money won’t solve everything, of course. The FDA has some organizational and strategic priority choices to confront and reconsider, in addition to getting new people up to speed, and it also needs to work on bringing its medical device class and subclass system into the 21st century, Mansour adds.

But even in these days of cutting political partisanship, almost everyone echoes Mansour, “All agree the FDA’s function is critical.”