The Consumer Healthcare Products Association's next president, Scott Melville, says his Rx manufacturing and distribution experience provides a foundation for "navigating a complex regulatory structure" in his first position on the OTC side of the drug industry.

The trade group Sept. 28 said Melville, currently senior VP for government affairs and general counsel for the Healthcare Distribution and Management Association, will start as CHPA president Nov. 1, succeeding Linda Suydam.

Before joining HDMA in 2004, Melville served as an attorney and head of government relations for Cephalon Inc., and in public policy and government affairs positions at Hoffmann-La Roche and Sterling Winthrop. He also is a former chairman of the Pennsylvania Biotechnology Association.

"My two decades of experience in the pharmaceutical industry is really a great background for navigating a complex regulatory structure on behalf of companies who are engaged in that. It's experience that I'll be able to bring to the table immediately," Melville said in an interview.

"Obviously, prescription drugs are regulated similar to but different than over-the-counter products. I think that as the OTC industry has become more regulated and as legislators are looking more into the area, I think this kind of experience that I've been able to acquire will be very valuable in representing this industry as well."

He pointed out that like the OTC regulatory scheme, marketing practices for the products also will be new to him.

"The very interesting perspective that I'll be learning here at CHPA is the consumer side. That's something that in the pharmaceutical industry or the distribution industry we don't touch as directly," Melville said.

"I think what's interesting and what will be a great area to build upon at CHPA is the fact that these products are directly marketed to the consumer."

Maintaining OTC Access Is Key

He added that CHPA's work to maintain OTC access to nonprescription medicines is "a very appealing aspect of this position."

The trade group's most recent work on the OTC access front came in presenting information to an FDA advisory panel that recommended against scheduling dextromethorphan as a controlled substance, which would have ended nonprescription sales of one of the most common OTC cough suppressants (¹ Also see "DXM Panel Proposes Augmenting, Improving Education To Curb Abuse" - Pink Sheet, 20 September, 2010.).

CHPA's defense of OTC access in recent years included addressing the safety and efficacy of pediatric cough/cold OTCs and whether FDA should establish a behind-the-counter status for some nonprescription drugs (² Also see "FDA Panel Narrowly Votes Against Cough/Cold Drugs For Children Up To Age 6" - Pink Sheet, 22 October, 2007. and ³ Also see "BTC Proponents Cite Pharmacists’ Role; Opponents Question Need" - Pink Sheet, 19 November, 2007.).

The next regulatory challenge the trade group and its members may face could be a congressional push for tighter manufacturing controls following Johnson & Johnson business McNeil Consumer HealthCare's recalls in 2010 of pediatric products including Children's Tylenol (see story p. 5).

Common Denominator: Supply Chain Security

Melville said he was not ready to comment on regulatory or legislative issues that will be priorities when he starts at CHPA. But he noted supply chain security is a crucial issue for Rx drug manufacturers and distributors and is becoming more important across the industry.

"I think the whole issue of supply chain security has been a top priority of our organization here at HDMA since I joined and obviously for years before my joining as well. But there's been a real enhanced emphasis on that under the leadership of [President and CEO] John Gray and myself," Melville said.

"Supply chain security is an industry-wide priority. The folks who are trying to penetrate the supply chain are going to look wherever profit can be made. So the entire industry has been especially vigilant given some recent events. We're working together with other organizations to try to develop some best practices and directly with the FDA in identifying risk areas and where industry can work with the agency to tighten up in transit security."

Familiar In The Halls Of Congress

Prior to working in the health care industry, Melville was legislative counsel and Appropriations Committee associate on the staff of Rep. Jerry Lewis, R-Calif.

Lewis is the ranking member on Appropriations and, should Republicans gain control of the House in the November elections, he would be in line for committee chairman, a post he lost when Democrats claimed a majority after the 2006 elections.

Melville notes he "worked with all of the committees of jurisdiction for many years and understand[s] the role of Congress both in developing new policy and in oversight."

"Both of those areas are incredibly relevant to what the industry is going through right now and will continue to go through," he said.

"We are in a period of heightened regulation and oversight, appropriately so. I think that experience, having been on Capitol Hill and having worked with Capitol Hill for a long time, will be beneficial in this role."

Working With FDA

Suydam announced her pending retirement in March. She joined CHPA in 2002, succeeding Michael Maves, with 21 years of experience at FDA and a background including legislative affairs, international relations and public health (⁴ Also see "Suydam Retirement Announcement Sets Off CHPA President Search" - Pink Sheet, 15 March, 2010.).

At the time, several observers said the trade group's next president should be someone who can balance standing up to FDA and working with the agency.

Unlike Suydam, Melville never worked at FDA. Time will tell how well his career in the pharma industry has prepared him for the CHPA post.

"It remains to be seen if his government affairs background in Rx distribution channels transfers strategically to the self-care arena for an industry that needs strong leadership to gain momentum that will facilitate approval of novel Rx-to-OTC product innovations," said Bill Soller, a former CHPA executive who is professor and executive director of the Center for Consumer Self Care at the University of California, San Francisco, School of Pharmacy.

New Post Has Old Feel

Melville acknowledges the OTC industry learning curve he is approaching, but points out his responsibilities at HDMA are similar to those he will have at CHPA - working with pharmaceutical firms and regulatory agencies on legislative and regulatory issues.

"From my perspective it was an opportunity to head a health care association of similar size, membership and mission that will draw upon my broad industry experience and the complex supply chain relationships between manufacturers, wholesalers and retailers," he said.

"I'm passionate about issues. I like to be an industry advocate and I have to feel strongly about the issues I'm advocating on behalf of, when I look at this industry and the products they're producing. And providing patients with access to safe, convenient, reliable medications and treatments is something I feel really good about advocating on behalf of."

- Malcolm Spicer ( ⁵ m.spicer@elsevier.com )

Incoming CHPA Head Melville Brings Pharma Resume To OTC Learning Curve

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