The Health and Human Services Department is tightening the reins on the Food and Drug Administration, alarming career employes and raising fears that the agency's historical independence will be lost in the Reagan administration's drive to deregulate.
The changes are subtle, but critics point to increasing centralization of authority over the nation's oldest health and safety regulatory agency in the office of HHS Secretary Richard S. Schweiker and, ultimately, the White House.
Of greatest concern, they say, is Schweiker's move to reclaim authority over all major regulatory actions. That action also concerns some advocates of a streamlined regulatory process, who say it has resulted in more, rather than fewer, delays in an agency already accused of slowness by those on both sides.
The anti-regulatory push from the top, coupled with the Reagan administration's stronger emphasis on dollars and cents in regulatory actions, has already meant setting aside or scrapping several rules put forward by the Carter administration, including rules to keep closer tabs on adverse reactions to medical devices and to monitor the quality of infant formula. It has also meant a new commitment to faster drug approvals and revisions in food laws.
To the industries that FDA regulates, this is a good omen that an era of adversarial relations and long regulatory delays may be ending, and none too soon. But consumer groups see an erosion in the agency's commitment to aggressive enforcement of the law.
Total enforcement actions dropped by two-thirds in the Reagan administration's first 18 months in office, as compared to activities during equivalent periods in the Carter term, according to the Public Citizen Health Research Group, a Ralph Nader-founded consumer organization that monitors FDA activities.
FDA officials acknowledge some decrease in enforcement actions. But a spokesman says the raw numbers fail to indicate that many "corrective actions" are now achieved "voluntarily."
The Health Research Group disagrees strongly. "This drastic decrease in government policing of the industries FDA is supposed to regulate is an open invitation to drug companies and food companies to violate federal law, thus risking the health and lives of 230 million Americans," the group charged recently.
Consumer activists and congressional critics also point to these recent episodes:
* Late last year, the FDA put "in abeyance" a proposed rule that would have required medical device manufacturers to report to the agency any deaths or adverse reactions associated with their products. The government said it needed to assess the impact of the November 1980 proposal. Another proposal to restrict use of some devices was withdrawn entirely.
* There have been congressional charges that the Reagan administration's mandated "cost-benefit analysis" slowed down the issuance of a final infant formula quality-control rule that might have kept a defective product from getting on the market. Regulations first proposed under the Carter administration in December 1980 were not published in final form until April 20 this year.
FDA commissioner Arthur Hull Hayes Jr. acknowledged at a House Commerce Committee hearing that if a regulation had gone into effect, and been followed, the distribution of a potentially hazardous formula by Wyeth Laboratories would have been prevented. The formula was recalled in March of this year because the absence of a crucial vitamin could have caused convulsions and nervous system problems in infants. FDA says there have been no confirmed reports of injuries.
* In a separate set of infant formula recall regulations, a delay occurred after Schweiker's staff chastised FDA, at a meeting last fall, for writing a proposal they considered far too detailed. The proposal came out last January, with the final version published in late April.
* Despite Schweiker's announcement early last June that aspirin labels would be required to warn of the risk of a life-threatening condition called Reye's syndrome after aspirin use in children with influenza and chicken pox, the agency has not yet published the labeling proposal in the Federal Register, raising questions about whether the warning will be on aspirin packages when the flu season begins this fall.
* More recently, consumer and senior citizens' groups accused the government of exposing elderly people to a potentially lethal hazard by allowing the anti-arthritis drug Oraflex to be marketed here. Citing reports of deaths and adverse reactions in Great Britain, where the drug had been on sale for two years, the groups filed a lawsuit to get the drug off the market. The FDA was studying the problem when British health officials went ahead with their own halt in sales, and the drug's manufacturer, Eli Lilly and Co., voluntarily removed the drug from the market in the United States.
The FDA, established in 1906 to oversee the safety of the nation's food and drug supply and now the only regulatory agency in HHS, has always enjoyed a measure of autonomy in the government. But that autonomy increasingly has been a burr to industry, which has watched the agency's tentacles grow to embrace virtually every product that goes in the body or is sprayed or smeared on it.
FDA's regulatory reach extends to products that account for about 25 cents of every dollar spent by American consumers--including food, drugs, vaccines and cosmetics as well as medical devices, veterinary drugs and products that emit radiation.
Consumer groups argue that the public wants more, not less, regulation by the FDA. Dr. Sidney Wolfe, head of the Health Research Group, accuses HHS, with direction from the White House, of a "very strong pro-industry attitude" and a "tremendous scorn for issues that are important to the health of consumers."
But Wolfe and other consumer activists acknowledge that FDA has thus far undergone less change under the Reagan administration than some of its regulatory counterparts, such as the Environmental Protection Agency.
Some industries agree, none too happily. Privately, many company representatives complain that the administration has been unexpectedly slow in keeping its promises to speed up drug review, revise food safety laws and reconsider existing regulations.
"The oratory has been just fine. But what has happened concretely?" asked one impatient drug official late last spring. A June 24 announcement of an HHS proposal that would speed up new drug approvals was viewed as a major step in the right direction, but it has not received final clearance by the White House Office of Management and Budget. Proposals to speed up the research stage of drug development are not expected until later this year.
"I haven't seen any deregulation" in the food area, complained Sherwin Gardner, vice president of the Grocery Manufacturers of America and formerly an FDA official for nearly a decade. "For an administration that came in riding on a regulatory reform horse, they don't seem to have given that charge to FDA."
Peter Hutt, FDA's chief counsel during the Nixon-Ford years and now a Washington lawyer with food and drug business clients, warns that both industry and consumers may be adversely affected by what he sees as the Reagan administration's failure to follow through on its anti-regulatory "rhetoric."
Instead of "true regulatory reform," Hutt contends that "regulatory inaction" has largely been the result thus far, with a "substantial slowdown" in major activities across the board. "At all levels of FDA, regulatory efforts are being toned down, delayed and abandoned," he said.
"What troubles me is that the agency is stalled in the middle of nowhere and nobody is quite sure where they are going. There is no cohesiveness, no strong sense of direction and policy . . . . It's got to be the one agency in the entire world upon which we depend most," said Hutt.
Hutt and FDA insiders point to the transfer of authority to HHS, away from the professional employes at FDA, as the key to the regulatory bottleneck.
The formal move toward greater departmental control was made in a May 1981 Federal Register order that revoked authority that had existed for more than a decade allowing FDA to issue regulations without the approval of the secretary. A second order this spring extended the transfer of power.
Both actions, Hutt contends, created a "tremendous procedural roadblock" that was purposely "designed to slow down FDA activity." From FDA's view, with most staff located in a sprawling complex in Rockville, far from the center of power, much of what HHS has done amounts to increasing interference, rather than better management.
But Schweiker, who took the top HHS slot after 20 years of experience on Capitol Hill and more than a decade on a key Senate health subcommittee, says more control was needed because of greater involvement of the president's staff in monitoring all regulations. The changes under way at FDA, he said recently, are simply a matter of management style.
"I'm not going to sit back and play a passive role. I'm going to get involved," Schweiker said from his sixth-floor office at the HHS Hubert H. Humphrey headquarters building in Southwest Washington.
"He hit the ground running, as far as FDA is concerned," says HHS chief of staff David Newhall III. "I'm not sure we have achieved anywhere as significant a change as the secretary desires, but we're well on our way."
The Carter administration, too, took a tremendous interest in keeping a closer eye on FDA. But the actual paperwork on individual regulations and proposals was generally not sent downtown for extensive review and analysis, as is now the case for regulations considered "significant."
The most obvious impact on the slow-moving FDA has been further delay, although there are recent signs that the deregulatory drive at the agency may be gathering speed.
A July 2 Federal Register announcement listed 13 regulations that were targeted for special review by September 1983, to see if they pose "unnecessary burdens." They include rules or proposals involving manufacturing processes for foods, drugs and blood products, antibiotic certification, patient package inserts in drugs and even labeling of bubble bath products.
Despite administration pledges to end "regulatory overkill," the total number of regulations issued by FDA last year was about the same as in the year before, according to FDA's regulation chief, Joseph P. Hile. But most of those were routine and noncontroversial rule-makings; the secretarial-level slowdown affects only those deemed "significant."
"One impact is that things that the agency would have begun simply never get started because there is anticipation that there will be problems at a secretarial level," said ex-FDA official Hutt.
In other cases, FDA sources say that documents sent to HHS have met long delays and little feedback. For example, the already lengthy process to review the safety and effectiveness of over-the-counter (OTC) drugs includes scientific reports that are influential in deciding whether products remain on the market. Last year not a single OTC panel report was published. The speed has picked up this year, but some problems continue.
Another concern about the new review process is the potential for greater political influence. Most FDA officials maintain that so far, despite delays, the final decisions generally have been those originally advocated by the agency.
But consumer activist Wolfe contends that a decision to rescind a Carter-era pilot program to inform patients about the uses and side effects of prescription drugs was influenced by HHS and OMB pressures. The program, vigorously opposed by powerful medical and industry groups, was frozen after Reagan took office, and FDA proposed last December to spike it.
However, FDA did prevail on a proposal for supplying information on salt content when foods have nutritional labeling. Although the proposal did not go far enough for consumer groups advocating mandatory labeling, it went too far in the opinion of groups like the American Bakers Association. The bakers took their case to the White House, so far without success.
Internally, HHS has also assumed greater powers in the naming of outside technical advisory committees, a practice that FDA staffers fear could lead to selections on the basis of party politics. Several candidates considered for sensitive advisory positions had connections with Republican causes.
"The agency has lost what measure of independence it had, and lost its insularity from partisan politics," lamented one longtime FDA official.
Outwardly, relations at the top of HHS and FDA have never been better. In separate interviews, Schweiker praised Hayes -- "I am very pleased with him" -- and Hayes stressed his "excellent relationship" with his boss.
But staff relations appear to be more strained, as seen in a recent Hayes memo to Schweiker questioning proposed changes in authority. Although he acknowledged HHS' right to policy oversight of FDA, Hayes complained that it is "impractical for the office of the secretary to attempt to manage the daily operations of an agency activity." He also worried that "any withdrawal of delegations of authority signals outside groups" that "there is a lack of confidence in FDA leadership."
One area in which Schweiker and Hayes have a strong mutual interest is in speeding up the drug approval process, a problem that has plagued several previous administrations.
The first fruits of the new effort came in Schweiker's recent announcement of a proposed major overhaul in FDA requirements for marketing new drugs. He promised to reduce paperwork for new drug applications by as much as 70 percent and cut review times for drugs, on the average, by 20 percent.
Schweiker says "beneficial drugs can be on the market, helping people, sooner," while all the current safety standards are maintained. Among the changes proposed are acceptance of summary tables rather than individual case reports on drug study participants, as well as greater reliance on foreign test data.
But critics of the rush to reduce the "drug lag" worry that too much faith will be put in drug companies and that the American public may be subjected to a greater number of pills with possible adverse side effects. They note that many of the drugs that will be approved more quickly are similiar to those already on the market and don't offer any major new treatment benefits.
The recent case of the anti-arthritis drug Oraflex is cited as a case in point. "What was the great advantage of Britain getting the drug before us? How many more deaths might there have been?" asked a House staff member, noting that in the two years' marketing time there, 61 deaths have been linked with the drug, compared with 11 in the three months it was on the U.S. market.
Food law changes have also been promised and an administration task force has already suggested revisions in the controversial Delaney Amendment, which prevents cancer-causing chemicals from remaining on the market, whatever the degree of risk.
While consumer groups vow to fight the changes, the industry isn't entirely satisfied either. Grocery Manufacturers' executive Gardner argues that the effort has been "unnecessarily slow" and warns that if the Reagan administration doesn't act soon on its initiatives it will be too late to get them through before 1984.
Less visible is the downward slide in the basic but unheralded monitoring of food and drug production that is the bedrock of the agency.
Statistics vary, even within FDA, but generally show a decline. The Health Research Group's analysis of enforcement actions from FDA's computer files showed a 58 percent drop during fiscal 1981, deepening to 66 percent during the first half of fiscal 1982.
FDA officials contend they are still able to protect against unsafe foods and drugs, but say the greatest effect has been in the area of "economic fraud," where some companies' products are not meeting their labels' promises.
They say the reductions in enforcement actions result not only from voluntary cooperation with industry, but also a decline in resources beginning at the end of the Carter administration and continuing under current and proposed Reagan budgets.
Although FDA has done relatively well compared with other agencies with more devastating cuts -- FDA's roughly $330 million annual budget has held relatively steady -- the people-intensive agency has lost more than 10 percent of its total staff. The loss in field inspectors has been even greater.
"It's not a crisis situation," says one FDA staff member, but another says it presents a "long-term problem." Even the optimistic Hayes admitted that the worst part of his job was "constant concern about budgets and personnel, uncertainty about what's going to happen tomorrow."
Most of those interviewed remain hopeful, however, that regardless of the philosophical stripes of the administration in power, no politician would risk cutting back FDA too far.
"The changes I see at FDA are much less noticeable than at other agencies . . . . The public has come to trust the food and drug supply and I don't think any administration is willing to tamper with the fundamentals of that," said one top official. "No one gets votes for unsafe drugs or infested food."