Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

PMA TRANSITION MANAGEMENT UNDER STETLER WILL TAKE OVER ON STEP. 4: FIRST DAY-TO-DAY PRIORITIES ARE NDA APPROVAL PROCESS AND ASSN. BUDGET REVIEW

Executive Summary

PMA's transition management under former President Joseph Stetler takes over day-to-day operations at the assn. on Sept. 4. The assn.'s Exec Cmte. agreed Aug. 22 to ask Stetler to return to the top spot at the assn. until a permanent successor to Lewis Engman can be found. Stetler will be at PMA on a part-time basis during September and will move to the assn. on a full-time basis in October. The former PMA president is resigning from his current position as a partner with the D.C. firm of Dickstein, Shapiro & Morin. Engman's resignation is effective Sept. 1. During the transition period, Stetler will have broad executive authority to initiate policy discussion and projects, review assn. personnel needs and address budget matters. Stetler will also work closely with the Exec Cmte. of the assn. on the search for Engman's successor. The most pressing issue for Stetler will be monitoring the ANDA/patent restoration legislation through its last steps on Capitol Hill (the House and possibly a House/Senate conference). The new interim president may face some difficulty working with House Health Subcmte. Chairman Waxman (D-Calif.) to get the amended Hatch (R-Utah) bill through the House. Waxman and Engman had developed a strong joint commitment to the House version of the bill. As a new personality in the negotiations, Stetler may come up against resistance from Waxman's staff. While Stetler Could Have Awkward Time With Waxman Subcmte., ANDA/Patent Bill Is Not Jeopardized However, the amended Hatch Senate bill has gotten considerable play in the lay media as a consumer-oriented piece of legislation; and it is difficult to imagine Waxman turning his back on the legislation with that type of publicity. The Hatch Senate bill is also getting close scrutiny from Chairman Kastenmeier's (D-Wis.) Courts Subcmte. ("The Pink Sheet" Aug. 20, p. 11). During Senate debate on the bill on Aug. 10, Hatch implied that Waxman has already approved the Senate changes by reporting that Waxman was involved in the Senate amendments. Hatch said: "Further negotiations ensued (on Aug. 9) with Congressman Waxman . . . in an attempt to develop a final position which would be satisfactory to everyone. I am pleased to report that these negotiations bore fruit." In addition to the ANDA/patent restoration bill, Stetler is likely to devote much of his time to developing a PMA strategy for improving the NDA (new drug approval) process at FDA. Stetler was going to head up a project on that issue from his position at Dickstein, Shapiro. He will now be able to commit more PMA staff time to that effort. The NDA approval project is considered a high priority by the PMA board. A special cmte. under the direction of Roche President Irwin Lerner has been assigned to assess alternatives to the current review procedures. The board cmte. is scheduled to hold its first meeting soon after Stetler reassumes the top position at PMA. PMA is taking up the NDA review procedures issue at a good time. The new FDA commissioner, Frank Young, was urged by HHS Secty. Heckler to meet with leaders from industry as part of his get-acquainted period at the agency. PMA could try to arrange a session with Young as a point of departure for reviewing the NDA process. FDA is just finishing its four-year project to clarify the types of NDA and IND submissions, but PMA wants to look at more fundamental changes in the review process -- such as greater use of outside advisory bodies or increasing the weight of advisory cmte. decisions. In the FDA relations area, the assn. will probably begin to rebuild the technical liaison work with the agency on such subjects as good manufacturing practice issues, animal testing, etc. A number of those issues, which entail time-consuming cmte. work within the assn., were avoided during the patent restoration push. Stetler will also address the assn.'s budget in preparation for a new president. The four-year patent restoration lobbying campaign has been a costly effort for the assn. and has depleted cash reserves. At its Phoenix annual meeting in May, the assn. reported that it was able to replace about $400,000 of the reserve will excess funds from last year's budget. It now has about $1 mil. in reserve and an annual budget of $10.3 mil. in 1984 -- a relatively low reserve position for an assn. Some of the initial savings could come from reductions in outside consulting fees. The assn. made heavy use of outside lobbyists during the Hill maneuvering on the patent restoration bill. A recent list of lobbyists for the assn. shows 10 active outside groups, including former House Judiciary Cmte. member Tom Railsback and the law firm of O'Neil & Haase. The assn. has also invested a lot of money in preparation for the internatl. marketing controls issue. Engman identified the internatl. arena as a major upcoming challenge for the U.S. drug industry. An expanded PMA effort in that area is likely to continue under new leadership. The assn. has created a special board cmte. a handle the internatl. issue also. The argument for proprietary marketing rights could, in fact, be enhanced by the patent revisions which would put the U.S. govt. on record as reiterating the importance of marketing exclusivity as an incentive to new product development in the Rx area. There are four top executive positions within PMA open as Stetler takes charge: the permanent presidency; the top administrative officer; and top Capitol Hill liaison; and top public relations officer. Stetler will be able to recruit for those jobs prior to the choice of the new president. The PMA Chairman, W-L President Joe Williams, will assist Stetler in major personnel decisions. One issue that Stetler won't have to spend much time on during his interim tenure is the re-establishment of close ties with other health trade groups. PMA's ties with those groups haven't been very close in recent years. Stetler has kept up with most of the major health assns. during his years in private practice, representing both APhA and NWDA on a number of recent issues. A former partner of Stetler's from private practice, Frank Samuel, heads the medical devices and diagnostics trade group, HIMA.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1134044

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel