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Making Sense Of DOT & FDA Regulations

Tuesday, May 22nd, 2012

Making Sense of FDA & DOT RegulationsRegulations can be not only hard to keep track of, but hard to make sense of at times, whether it’s FDA medical gas regulations, DOT driver regs, OSHA or other standards. Thankfully for GAWDA members, the association has enlisted its consultants to help simplify this Sisyphean task.

Yesterday, two of GAWDA’s consultants delivered a regulatory update for members. Rick Schweitzer, Government Affairs, Human Resources & Legal Consultant, updated members on the latest driver regulations, including hours of service, EOBRs and the Certified Medical Examiners Registry.

There seem to be quite a few regulations up in the air as it relates to drivers in the gases and welding industry. One such issue is the tank vehicle definition. FMCSA quietly redefined its definition of tank vehicle in a way that would have required distributors hauling cylinders or tanks above a certain quantity to obtain a tank vehicle endorsement, even if the trucks are not carrying hazardous materials. With the rule having faced a great deal of criticism, Schweitzer reports that FMCSA will reconsider the tank definition. There’s only one problem. Several states have already started enforcing the new definition (they were not required to enforce it until 2014), creating confusion and an additional burden. It may be within their right, but is it fair for states to enforce a rule that’s under review?

There’s also quite a bit of regulatory anticipation on the medical gas side, as reported by FDA, Medical Gases and Specialty Gas Consultant Tom Badstubner. As I’ve mentioned in previous posts, there have been discussions about whether medical gases should be regulated differently than other drugs. But aside from the regulatory uncertainty of medical gases, distributors of food-grade gases face an increasingly uphill terrain. As Badstubner explained, food gas distributors are now being looked at as food producers, and as such, are inspected as though they ran a bakery. This means distributors may need to keep logs of cleanliness and check for infestations much like a bakery.

I’m only skimming the surface of the regulatory issues at hand. As Schweitzer and Badstubner pointed out, part of members dues’ pays for access to the consultants. So if you have regulatory questions, they are a great resource. GAWDA’s consultants also each write a regular column in Welding & Gases Today, which are all available online. Find answers to your regulatory questions in the Consultants’ Corner Archive.

Congress Talks About Medical Gases

Friday, March 9th, 2012
Congressional Hearing on Medical Gases

LifeGas President Michael Walsh testifies before Congress.

If you are a follower of mine on Twitter, you may have noticed that there was a Congressional hearing about medical gas regulations on Thursday, March 8. Among the many issues discussed were the regulatory challenges facing medical gas manufacturers and distributors. The underlying problem is that medical gases like oxygen, nitrogen and carbon dioxide are currently subject to the same regulations as pharmaceutical drugs, despite entirely different manufacturing distribution processes. Many in the gas industry believe that FDA needs to develop regulations that are targeted at medical gases specifically.

The industry has made a lot of progress on this front recently, as evidenced by the proposed Medical Gas Safety Act (HR 2227), introduced by Rep. Lance and cosponsored by members from both sides of the political aisle. The Congressional hearing was another step forward, as the industry was given a forum to plead its case. The Compressed Gas Association was represented by LifeGas president Michael Walsh.

In watching the hearing, I was shocked to learn that gases like oxygen are considered “unapproved drugs” in some venues. The problem, as Walsh explained, is that many customers are scared off by the “unapproved” label, causing them to cancel orders. The Medical Gas Safety Act would help resolve this by creating a process for medical gases to gain approval.

Another issue is expiration dates, which some government agencies attempt to enforce on medical gases. Walsh says, “Oxygen is an element of the periodic table. By its basic properties it will never expire.” Overall, Walsh was extremely well spoken. Let’s hope Congress and the FDA agree. You can read Walsh’s initial testimony here, or view the discussion in the video below.

From here, the next step for CGA is lobbying to have the Medical Gas Safety Act included with the Prescription Drug user Fee Act (PDUFA). At this point, there is a chance that FDA could attempt to block this effort, but there is hope. Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, also testified at the hearing. Dr. Woodcock said the FDA would be willing to work with CGA and industry manufacturers to come to a mutually beneficial solution. We’ll see what happens from here.

What do you think: Should the FDA adopt separate regulations for medical gases? How is your business affected by the current lack of specific medical gas regulations?

If you missed the Twitter chat yesterday, you can catch up by checking out hash tag #medicalgas.

View the Congressional hearing below or watch it on YouTube. It’s kind of a long one, but worth watching the discussions about medical gas.

Social Media Regulations…From FDA

Tuesday, January 11th, 2011

FDA's social media regulationsAmong the more unusual regulations that we might see in 2011, FDA is slated to publish draft guidance on the use of social media. Yes, you read that correctly. A recent message from the Division of Drug Marketing, Advertising, and Communications (DDMAC) says that the division has “been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:

• Responding to unsolicited requests
• Fulfilling regulatory requirements when using tools associated with space limitations
• Fulfilling post-marketing submission requirements
• Online communications for which manufacturers, packers, or distributors are accountable
• Use of links on the Internet
• Correcting misinformation”   (via EyeOnFDA.com)

The agency is targeting a publish date of 1st Quarter 2011, so we should see this very soon. One bullet points specifically to the online communications of distributors, so this will impact those GAWDA members who manufacture or distribute medical gases.

I was surprised to learn that the FDA was stepping into the realms of Twitter, Facebook, LinkedIn, et al, but it does make sense to a certain extent—social media are largely unregulated. We’re in a new age with social media, and with it come unique challenges. Bullet #2 raises an intriguing point: how do you meet regulations when Twitter limits your characters?

I’m still undecided on this, but I want to hear what you think: Has the FDA overstepped its bounds, or do you welcome the idea of social media guidelines? What social media issues would you like guidance on?

How A Resolution Becomes A Regulation

Friday, January 7th, 2011

In my last post (Resolutions For A New Year), I talked about setting resolutions for 2011. As I learned from Ned Lane’s article “Top 5,” communicating those goals to others can help you accomplish them. Not only does it create accountability, but it can enable those around you to provide any needed support. If they don’t know about it, they can’t support you.

While I was thinking about resolutions, I thought, wouldn’t it be great if federal agencies made New Year’s resolutions, too? With a steady stream of changing regulations, compliance in itself can be a full time job. If we knew ahead of time what was on the agenda, it might help distributors be ready and, in turn, allow them to help their customers prepare.

Although the government doesn’t issue its own New Year’s resolutions as such, I’ve tracked down some of the items they’ll be paying attention to this year:

• First, GAWDA’s FDA & medical gases consultant, Tom Badstubner, looks at the medical gases initiatives planned by the FDA, Congress and the USP. Among the potential changes are new guidance from the FDA and medical gas monographs from the USP.

• For truck drivers, GAWDA Government Affairs, Human Resources & General Counsel Consultant Rick Schweitzer reports that Hours of Service could be changing. Follow the link to find out what changes your company may have to make to dispatch and driver management protocols.

• OSHA recently released its regulatory agenda for the next year. Changes to OSHA’s Hazard Communication Standard may be impacting distributors in August 2011, and they should keep tabs on combustible dust rulemaking that may be impacting their customers.

• Among EPA’s regulatory priorities, the agency’s attention to indoor air quality could have an impact on the welding industry (pp. 79845 – B2).

• For an overall look at coming changes, take a look at the “Top 11” regulatory changes in 2011 as compiled by Paychex, Inc. Of note are changes in tax law, allowing businesses to expense capital investments and healthcare reform. These should be on the radar of any business owner/operator.

What regulations are you watching for in 2011? What will impact you and your customers most?