HOUSE COMMITTEE ON HEALTH AND HUMAN SERVICES

 

March 26, 2003   Hearing Room D

8:30 A.M. Tapes 65 – 68

 

MEMBERS PRESENT:            Rep. Jeff Kruse, Chair

Rep. Billy Dalto, Vice-Chair

Rep. Carolyn Tomei, Vice-Chair

Rep. Gordon Anderson

Rep. Jeff Barker

Rep. Laurie Monnes Anderson

Rep. Ben Westlund

 

STAFF PRESENT:                  Sandy Thiele-Cirka, Committee Administrator

Mara McGraw, Committee Assistant

 

ISSUES HEARD:                     Informational Meeting

                                                            Pharmaceutical Development

·         John Swen, Global Research and Development, Pfizer, Inc. From Molecule to Market

·         Russ Spencer, Pfizer, Inc.

 

These minutes are in compliance with Senate and House Rules.  Only text enclosed in quotation marks reports a speaker’s exact words.  For complete contents, please refer to the tapes.

 

TAPE/#

Speaker

Comments

TAPE 65, A

005

Chair Kruse

Calls meeting to order at 8:50 A.M. and opens informational meeting.

INFORMATIONAL MEETING

022

Russ Spencer

Pfizer, Inc. Notes presentation represents Pharmaceutical Research Manufacturers of America (PhRMA) as a whole.

035

John Swen

Senior Director, U.S. Science and Policy, Global Research and Development, Pfizer, Inc. Presents power point on prescription drugs: Molecule to Medicine (EXHIBIT A). Relates complexity of creating products for diverse environments, individuals and markets.

098

Rep. Westlund

Inquires on regulations for international production and marketing.

104

Rep. Dalto

Inquires on similarity of markets within the world wide market and questions top selling drugs.

107

Swen

Explains issues related to regulatory and patent process.

130

Rep. Dalto

Questions if drugs have the same composition in each country.

133

Swen

Responds affirmatively. Notes price of prescriptions relates to clinical and research guarantees. States more revenue generates more research in turn generating more products. Continues presentation. 

173

Rep. Tomei

Questions the current assault on prescription drug companies.

174

Swen

Explains impact of media and criticism on development of medicines and drug companies. Addresses marketing budget compared to the research and development budget.

269

Rep. Tomei

Inquires on patent timeline.

270

Swen

Reports 17 years in United States. Explains that 10-12 years are spent in development.

277

Rep. Westlund

Inquires on percentage of marketing to research and development.

281

Swen

Reports 30-40% of budget is directed at marketing. Discusses the complexity of drug development as it relates to costs.

313

Rep. Dalto

Questions scientists’ compensation.

315

Swen

Explains compensation is competitive with general scientific market. Discusses research process relating to diseases and cures. Notes role of National Institute of Health (NIH) is training not development. Reports private companies file 95 percent of patents.  

382

Rep. Anderson

Questions Pfizer’s hiring from NIH.

383

Swen

Reports Pfizer hires primarily from NIH.

392

Rep. Monnes Anderson

Inquires on collaborations with universities.

407

Swen

Discusses research collaboration with labs world wide.

450

Rep. Tomei

Inquires on benefit to lab when Pfizer develops drug.

TAPE 66, A

015

Swen

Explains research and financial benefits to universities and labs. Details several phases of drug development.

095

Rep. Dalto

Questions Phase II studies.

097

Swen

Explains Phase II research studies are performed with healthy adults.

197

Chair Kruse

Inquires on Phase III studies relating to genome mapping.

202

Swen

Defers answer until later in presentation. Continues presentation on drug development, development timelines and patent process.

222

Rep. Dalto

Requests information on negotiation of reimbursement rates in Europe.

228

Swen

Elaborates on drug development and reimbursement process in Europe and impact on European research and development labs.

252

Rep. Dalto

Clarifies dictation of cost in Europe negatively impacted European drug research.

246

Swen

Concurs.

257

Rep. Anderson

Questions the patent extension process.

261

Swen

Explains patent of control release formulation and impact on patent timeline. Details the patent process guidelines.

302

Rep. Tomei

Questions the number of patents extensions.

304

Swen

Offers to present information at later date. Continues presentation on drug development, price controls and patents as they relate to replication by other manufacturers.  

378

Rep. Dalto

Inquires on timeline of drug to market in regard to patents.

383

Swen

Explains regulatory timeline and process. Discusses capitol investments on drugs brought to market. Notes brand drugs subsidize development of other drugs in pharmacopoeia.   

445

Rep. Tomei

Questions if data presented is current.

448

Swen

Notes new study recently completed. Offers updated data in capital returns.

TAPR 65, B

037

Rep. Monnes Anderson

Inquires on pricing drugs out of business.

043

Swen

Comments on patient access programs offered by Pfizer. States the problem is coverage not cost. Speaks to maintaining brand companies to support research and development which supports generic industry. Explains that generic companies do not have the profit to support research and development.

132

Chair Kruse

Questions the impact of tort on mergers.

133

Swen

Speaks to drive toward mergers.

180

Rep. Dalto

Comments on the filter of data application.

183

Swen

Responds and explains that small companies are commercially validated. Notes that small molecule companies as compared to biotechnology companies. Explains the scale of clinical and regulatory infrastructure required to generate profit.

241

Rep. Monnes Anderson

Speaks to consolidation issues.

246

Swen

Notes natural consolidation. Identifies pressures that drive consolidation.

262

Rep. Tomei

Inquires on number of manufacturers belonging to PhRMA.

263

Swen

Estimates 90 percent belong to PhRMA. Reports data on current disease prevention and elimination as result of drug research and development. Discusses increase in life expectancy as it relates to technology.

310

Swen

Continues presentation. Comments on demand for better health care and the cost of drugs relating to disease prevention.

400

Swen

Addresses technical differences and clinical results.

TAPE 66, B

010

Swen

Continues presentation and offers examples of innovation and subsequent results. 

042

Rep. Tomei

Comments on direct consumer advertising creating demand.

044

Swen

States no evidence to support alleged increase in demand due to direct consumer advertising.

053

Rep. Tomei

Questions purpose of advertising.

054

Swen

Explains impact of marketing. Discusses types of impacts as a result of direct consumer marketing.

117

Rep. Dalto

Comments on warning labels. Notes role of doctors in prescription consumption.

139

Swen

Responds and comments on the diet drugs marketing.

150

Rep. Barker

Comments on impact of marketing certain drugs.

159

Swen

Notes unintended response of consumer’s to seek medical attention due to marketing.

178

Rep. Anderson

Compares consumer drive to that of dental patients.

185

Spencer

Relates personal experience with physician.

219

Rep. Tomei

Relates example of car sales to drug sales.

226

Swen

Responds that advertising is intended to sell drugs.

236

Rep. Anderson

Comments on the results of marketing help to support future drug development.

247

Swen

Concurs.

250

Rep. Dalto

Comments on promotional tools. Requests information on ratio of detailing to direct consumer advertising.

258

Swen

Reports figures for detailing and states that the cost include free drugs. Conveys that general promotional tools are used by all manufacturers,

290

Rep. Dalto

Comments on ratio of funds spent in other areas compared to drug manufacturers.

298

Swen

Indicates that Pfizer is in business to offer returns to shareholders. Requests criticisms should be put in perspective. Reiterates issues related to promotion of specific drugs.

349

Rep. Dalto

Reiterates expenditure ratios of detailing and direct consumer advertising.

361

Spencer

Clarifies regulations and role of detail representatives.

384

Swen

Continues presentation. Addresses issues related to closed formulas in which one drug is selected for Medicaid coverage.

TAPE 67, A

010

Swen

Continues presentation on drug development. Speaks to timing of market.

018

Rep. Westlund

Inquires on regional based and locally developed formularies.

039

Swen

Notes restrictions are based on price of drugs. Comments on impact to future research. Addresses total health care costs as they relate to drug silos.

066

Rep. Westlund

Speaks to long term savings in health care.

069

Swen

Discusses health maintenance organization (HMO) incentives. Addresses risk sharing as it relates to acute cost elimination and long term care. Reviews formularies and cost savings.

111

Spencer

Addresses level of restrictions on formularies.

131

Rep. Westlund

Comments on solutions.

145

Swen

Remarks solutions lie in technology. Continues presentation. Discusses relationship of human genome research to drug research and development. Compares current research capabilities to that of 10 years ago. Notes risks of unprecedented measures.

195

Chair Kruse

Comments on effectiveness of targeted cures and market returns.

208

Swen

Relates impact of phenol-type research on treatment and market.

246

Chair Kruse

Questions phenol-typing and genome mapping as it relates to marketing and returns.

273

Swen

Responds that it provides the ability to sustain research and development.

303

Chair Kruse

Inquires on role of Federal Drug Administration (FDA) in shortening process.

308

Swen

Explains work with FDA. Concludes presentation on drug development. Notes international purchase price parity data. Expresses concern over short-term solutions in regard to long term cost controls.

396

Rep. Westlund

Inquires on poly-medication usage.

405

Swen

Speaks to drug interactions and reports that patient pharmacopoeia management is beyond scope of pharmaceutical manufacturing companies.

505

Chair Kruse

Closes informational meeting and adjourns at 11:05 A.M.

 

TAPE 68 reflects only overlap testimony from TAPE 67, A.

 

EXHIBITS

 

A – Informational meeting, Power Point Presentation, John Swen, 30 pp.