CHPA Year In Review: Legislative Accomplishments, OTC Product Awareness And Goals For 2006

The Consumer Healthcare Products Association speaks to "The Tan Sheet" about the group's accomplishments in 2005 and plans for 2006. The 125 year-old trade association represents the interests of the consumer healthcare and over-the-counter drugs industries. Find below excerpts from an interview with CHPA President Linda Suydam and Vice President - Government Relations Kevin Kraushaar.

Achievements On The Hill

"The Tan Sheet": In 2005, CHPA has been actively lobbying Congress to pass laws to benefit consumers and industry. What would you characterize as CHPA's most significant legislative achievement this year?

V.P. - Government Relations Kevin Kraushaar: The biggest accomplishment for this year, and maybe even over the last several years, has been finally getting something done on methamphetamine. We were obviously very concerned about national Schedule V of pseudoephedrine. So the bill that has passed, or we hope that will be passing soon, is much more to our liking than the Combat Meth Act as it was originally introduced by Senators Jim Talent (R-Mo.) and Dianne Feinstein (D-Calif.) and Congressman Roy Blunt (R-Mo.).

We've had some meetings within the last 24 to 48 hours trying to find out where the Patriot Act is and what is going to happen and I think things are still unclear. However, staff seem rather adamant that it would be their intent to keep [the Meth Act] on the Patriot Act because they're concerned about getting it done in the Senate if it's not attached to a conference report, and so we're confident that will happen.

I know that they are working on some technical things, both with the Patriot Act and the Meth Act, to kind of ease it through a little bit more and we'll continue to consult with folks about those technical changes. The Patriot Act, I'm not sure. The technical things on the House bill are still in play but they have to do with the daily retail sales limit that's in the bill and the two different implementation dates for the bill.

One part of the bill is effective 30 days after enactment, the other part of the bill is effective Sept. 30, 2006. And so there is simply some technical language that needs to be worked out in both of those things.

"The Tan Sheet": What are CHPA's plans for continuing to work with Congress on meth issues in 2006?

Kraushaar: We'll continue to keep working on the issue until the Patriot Act is passed and finalized, but beyond that, at the federal/congressional level, what we'll be lobbying on is in support of additional appropriations for law enforcement, for [the Substance Abuse & Mental Health Services Administration], or other agencies involved in the enforcement of the provisions, whether it be DEA, or Justice, SAMHSA in the treatment programs...and the demand-reduction side.

Money, obviously, is the whole key to this; this is what we've been saying all along. So our lobbying on the meth issue won't stop with the passage of the meth bill - it will continue. It will just...shift from the authorization committees to the appropriations committees.

We're very happy with the state of the Meth Act - the state of where the legislation is and that Congress is finally getting behind us - and we look forward to working in the future to make sure that the law is fully implemented and fully funded as far as law enforcement by making sure they have the resources to implement the statute and make sure there is plenty of money available for treatment, education and demand reduction.

PSE Importation

"The Tan Sheet": CHPA has mentioned industry's support of "strong congressional efforts to pressure countries that do not properly monitor exports of bulk pseudoephedrine to the US and Mexico." What is being done to prevent illegal shipments of bulk PSE?

Kraushaar: Most of that is dealt with in the meth bill thanks to Congressman Mark Souder (R-Ind.) who has put language in on quotas and things like that. We have felt for many years that there's a discrepancy between what the DEA reports as far as [bulk] pseudoephedrine being brought into the United States and what our members are using to manufacture legitimate products.

We would support any tightening of the restrictions on the importation of bulk pseudoephedrine because we need to get a better handle on the difference between what our members are using and what the DEA says is coming into the country.

[Editor's note: For more information about the Combat Meth Act and the Patriot Act please see ¹ "The Tan Sheet" Nov. 28, 2005 , p. 3 and related stories.]

Hopes For FDA In 2006

"The Tan Sheet": What FDA-related issues is CHPA working on this year?

Kraushaar: One thing that's always important is the funding for FDA. That's kind of an ongoing issue for us. We're working with the appropriators as much as we possibly can to express the need that we think the FDA is under-funded. We would certainly like to see - from the OTC side - the monograph process completed.

We've been working on both the dietary supplement and OTC sides with members of Congress on adverse event reporting. For monographed OTCs, we're in support of that if that comes into place as we hope it will this year. We want to make sure the agency has enough money to receive the reports and to do the right thing with them and that's to analyze them - obviously - and detect signals on safety issues.

President Linda Suydam: Rx-to-OTC switch is incredibly important to us. As an industry, I think it's incredibly important to the American public because as we've seen with the most recent switches of loratadine (Schering-Plough's Claritin )...and(Astra Zeneca/Proctor + Gamble's) Prilosec OTC , it opens up new categories of products to the American consumer.

We want the switch process to be as predictable and as transparent as possible. What we've recommended to FDA is that the Office of Nonprescription Products should be in control of that process and get their input from the reviewing divisions in the Center for Drugs.

[Editor's note: ONP Director Charles Ganley, MD, noted in November that the office is, in fact, gradually taking over responsibility for reviewing Rx-to-OTC switch applications. See ² "The Tan Sheet" Nov. 28, 2005 , p. 4.]

Capitol Hill: Looking Forward

"The Tan Sheet": The association has been lobbying for a law to restrict the bulk sale of cough medicine ingredient dextromethorphan to only those companies registered with FDA. What progress has CHPA made so far?

Kraushaar: We're looking to support the introduction at the federal level which would make it illegal to sell bulk dextromethorphan to anyone who is not registered with FDA. You'd need a reason to have [dex]. And the reason to get that is that you would be registered with the FDA as a manufacturer, or a distributor, or a wholesaler or something like that.

We've talked to several members of Congress on this...and we're trying to get a cross-section of members of congress - probably the Energy & Commerce Committee, the Judiciary Committees and maybe even Education & Labor - to kind of cover all the bases on what needs to be done on dex.

First of all, the education side is very important: working with parents and working with teenagers to talk about abuse of dextromethorphan. [Secondly], the Judiciary Committee because we're looking to make it a new crime. And the Energy & Commerce Committee...and HELP (Health, Education, Labor & Pensions Committee) on the Senate side, because it does affect and impact an FDA regulated product so it would probably need three committee referrals.

We've been talking about [a dex bill] for four or five months now and I think we should have some news fairly soon once Congress comes back on Jan. 31.

"The Tan Sheet": Where does legislation to make OTCs eligible for tax deductibility rank on CHPA's priority list for 2006?

Kraushaar: Number one, without doubt. One of the more significant accomplishments for CHPA this year was the bipartisan, bicameral introduction of the bill.

[Editor's note: The "OTC Medicine Tax Fairness Act" was introduced in the House and Senate July 26, 2005.]

We think we've put together a pretty good group with Melissa Hart (R-Penn.) and Mike Ross (D-Ark.) on the House side, and Jim DeMint (R-S.C.) and Bill Nelson (D-Fla.) on the Senate side. Mike Enzi (R-Wyo.) is also a cosponsor on the Senate side so I think we've got a pretty good start. What we'll be doing in the next several months is trying to gather additional cosponsors for the bill so we'll be meeting with members of the Ways & Means and Finance [committees] in particular.

We'd certainly like to see it pass. We'll be also attempting to identify vehicles that it could be attached to - the reconciliation package, for example. We didn't have much luck [in 2005] on this issue just because there were so many other huge issues that needed to be dealt with in that package. Anything that has to do with healthcare reform, tax reform, tax simplification, could be potential vehicles for the bill. It could be added as an amendment to something bigger that's moving through.

So, we'll be taking two additional steps: one is to sign up additional cosponsors for the bill with the highest priorities being the Ways & Means Committee in the House and the Finance Committee in the Senate and then secondly, attempting to identify vehicles to which the bill could be added to as an amendment.

Another thing that's very high on our list of priorities is the flexible spending account rollover bill. It's been introduced and actually passed twice in the House and never been passed in the Senate.

Senator Chuck Grassley (R-Iowa), Chairman of the Finance Committee, is quite interested in the issue itself and has written to the administration asking them to do a rulemaking to simply allow for a $500 per year rollover from anyone having a flex spending account. The pension reform bill that passed the House has a provision in it which would enact the FDA rollover and the Senate pension bill does not. And so in the next couple of months, when the conferees get rolling on the pension reform bill, we'll be actively engaged in support of the House provision which is the $500 per year rollover.

There are significant savings to be made, significant health [benefits] to consumers and the fact that they can reimburse themselves for OTCs, an ever-growing part of the healthcare system, it's only that much more to the benefit of consumers.

[Editor's note: For more information on the OTC Medicine Tax Fairness Act" and FSA rollover legislation see ³ "The Tan Sheet" Aug. 1, 2005 , p. 7 and ⁴ "The Tan Sheet" May 23, 2005 , p. 11.]

CHEC Yourself

"The Tan Sheet": In the past year, what has been your overall biggest non-legislative accomplishment?

Suydam: I think the biggest accomplishment is the establishment and launch of our Consumer Health Education Center or CHEC. CHEC is very vital to increasing consumer confidence in OTCs by assuring they know how to use them properly. We want people to know that OTCs are real medicines that provide real benefits, but they also have real risks if they are used inappropriately.

Our launch was extremely successful. We've had a lot of hits on our website. We had 40,000 in the first day. That was for our Doctor in the House campaign which was focused on women. This is a program that really is based on research and science and we spent the first year looking at what consumers know about OTCs and how they use them. Then we looked at how we can help them change their behaviors.

"The Tan Sheet": How would you characterize the effect that CHEC has had on consumer education and awareness thus far?

Suydam: I think it's hard to say since we just launched in October...but I think it had an impact in making people aware and the website has gotten good traffic and that's very important. People need to have an impartial site where they can go and find out about the medications: the active ingredients, what the symptoms are, what they can be used for. So I think it's a long term project. It's something that's extremely important for our members because they want to make sure that consumers are using their products appropriately.

"The Tan Sheet": What are CHPA's goals for the program in 2006?

Suydam: We continue to have an extremely high goal in that we want to improve the health and well-being of Americans through the appropriate use of over-the-counter medicines. It really is a focus that is going to take a long-term commitment. It is a long-term commitment that our members have to product safety and to appropriate use.

We want increased exposure in the overall health care system because we think that OTCs are vital in the American healthcare system and will become increasingly so. As a result, you want to make sure that people know how to use them appropriately. So the time was right this year to launch a long-term program. It's going to take time. We started with women because we know that they make more than 75% of the healthcare decisions in their families, and they buy more than 75% of the OTC products. So we needed to focus on them first.

Our second program, which we'll launch in 2006, is going to be [focused] on older Americans, particularly those people who have multiple medications so that we can make sure that they're not using OTCs with prescription medications when they shouldn't be and that they know how to use OTCs properly. It's going to take a lot of time. We want to maximize the benefit of OTCs, and we want consumers to know how to do that.

We will partner with a lot of organizations. We've had great results from our first campaign. FDA was very impressed with it. We briefed the whole Center for Drugs hierarchy, and they are very interested in working with us on this project. And we will have other partners as well, especially as we move into the senior arena.

Drug Safety And OTCs

"The Tan Sheet": Drug safety has been a big issue at FDA during the past year and a half. Does CHPA have any specific initiatives related to these issues?

Suydam: I think that the drug safety issues, from an FDA perspective, were not really anything that affected OTCs that much. NSAIDs will be relabeled this year and we worked with FDA on that, and I think that's going to make it easier for consumers to understand the risks with those products and make sure that they have those risks in their minds as they weight the real benefits of those products.

I think OTCs clearly have high safety profile, particularly when they are used appropriately and as they are labeled. I think that the most important thing we can do with CHEC is to get people to understand the label and understand that the recommended dose is, in fact, the dose that they should be taking.

-Jessica Lake