Letters
Fixing Drug Review
The Public Health Security and Bioterrorism Response Act of 2001, signed by President Bush on June 12, extends the Prescription Drug User Fee Act of 1992. This law allows drug companies to pay higher user fees so the Food and Drug Administration can hire more staff to speed up review of new drug applications.
While an expedited review may be a good thing, more sweeping reform is needed to cure what ails America’s drug-review process.
Most people assume the FDA approval process ensures that a drug is safe and effective. But it’s not that simple. About half of all drug complications are discovered only after the FDA has approved a drug. Propranolol, a beta-blocker heart medicine, was approved and in use in Europe more than six years before it was approved in the U.S. Propranolol now saves about 10,000 American lives every year. Do the math. The FDA’s delay cost 60,000 lives during the six-year wait for approval.
Or take an example possibly costing lives today. An experimental vaccine has been shown to wipe out all cancer cells in most patients afflicted with follicular lymphoma cancer. Despite this apparent breakthrough, the FDA now is involved in the planning of a five-year randomized clinical trial of the vaccine. During these five years, about 282 patients with follicular lymphoma will receive the new vaccine while 20,000 other patients will be expected to die.
It’s time to reconsider the presumption that a monopolistic, centralized FDA is the only way to evaluate new drugs.
Countries in the European Union allow new drugs on the market by reciprocity,that is, if they’re approved by another EU country’s equivalent of the FDA. The EU countries also allow approval by the European Agency for the Evaluation of Medicinal Products. Competition causes government as well as private companies to perform more efficiently.
We also question whether the current “cartel” of the FDA, drug companies, and Organized Medicine is needed at all. The FDA could function as an advisory service, reviewing the results of drug tests and issuing advisory notices. But it would have no control over a doctor prescribing a new drug for a patient.
The decisions to approve any drug or device should be made by the patient and physician with advice from reviewers independent of both industry and government. Why? Because that’s where the ultimate medical reality is,not in the labs or bureaucracies.
Robert J . Cihak,
Michael Arnold Glueck
(Dr. Cihak, of Aberdeen, Wash., is a healthcare policy expert. Dr. Glueck, of Newport Beach, is a writer on medical issues and a Business Journal contributor.)
Paid Family Leave
A $23.6 billion state budget deficit and tax increases to solve it aren’t stopping the Legislature from proposing a new paid family leave program funded by new taxes for employers and working Californians.
State and federal laws already require employers with 50 or more employees to provide unpaid family leave under specified conditions. But SB 1661 (Sheila Kuehl D-Los Angeles) goes further, establishing for the first time a 12-week paid family leave program for all workers, regardless of the size of the company for which they work.
SB 1661 will increase the tax that workers pay into the state disability insurance fund and levy a new matching tax on employers. Our conservative estimates point to billions of dollars in new taxes for the first full year. If the first-year tax increase is just $2.6 billion (one of the lower estimates), that works out to a typical employee seeing a $102 increase in annual paycheck deductions, plus employers paying an additional $102 in taxes per employee each year. A family with two wage earners takes a double hit.
Even more troubling is that the thinking behind SB 1661 marks a significant departure from the original purpose of the SDI program. The program was set up using deductions from employee paychecks to partially replace wages for workers when they are unable to work due to their own illness or injury not related to work. The workers’ compensation program, funded through premiums paid by employers, is the safety net for workers injured on the job.
SB 1661 now seeks to use the state disability insurance fund to pay for time off for employees who are capable of working. To generate even more revenue to support the program, SB 1661 also imposes yet another tax on employers to pay for employees taking time off for reasons not related to work.
Providing workers with family obligations some financial help in grappling with the issues that generally give rise to a request for unpaid family leave is a laudable goal. But placing that burden on a system not designed to deal with it is not logical, nor is it prudent.
Mandating that employers pay the bill for employees who can’t go to work is unreasonable. Even the possibility that such a requirement will become yet another cost of doing business in California is likely to drive jobs out of state,not a desirable result considering the state’s budget woes.
Allan Zaremberg
President
California Chamber of Commerce
Sacramento
Energy, Cont’d
Last summer, instead of the widely predicted rolling blackouts, we saw wholesale power prices and natural gas costs decline to pre-crisis levels and we had sufficient power supply.
Energy price and supply security, however, remain vital issues, even more so now that we have been reminded, in the most violent of ways, just how exposed we are to forces beyond our control. Managing the energy challenge in today’s brave new world means ensuring not just the best bang for the buck, but identifying and making critical investments that reduce exposure to a higher level of risk.
And as we find ourselves in the hottest days of summer we see supplies growing tight. California’s Independent System Operator recently declared a Stage 2 power emergency because out-of-state imports were nearing dangerously low levels.
With limited options for tapping alternative suppliers, large energy users now must explore energy-efficiency as a major way to control their energy costs. Smart management of facilities’ water, space cooling and heating, as well as natural gas and electricity needs, increasingly plays a critical role in helping companies improve their bottom line.
Robert Dickerman
President
Sempra Energy Solutions
San Diego
