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The FDA’s Imprudent Caution

Tuesday, June 1, 2010

At a time when drug development should have been spurred by huge increases in r&d expenditures — which increased by more than 50 percent between just 2004 and 2008 (to $65.2 billion) — and by the exploitation of powerful new technologies, drug approvals by the fda have been disappointing. The 18 new medicines approved in 2007 represent the lowest figure in a quarter century, and the 2008 and 2009 tallies of 24 and 25, respectively, represent scant improvement. Current trends in regulatory policies and requirements will cause further deterioration in drug r&d and approvals.

The imposition of additional regulatory requirements and changes in policy by both the legislative and executive branches of the government will only further increase the time and costs of drug development, diminish competition, and make fewer new products available. The consistently risk-averse Congress has granted the fda additional powers that place new restrictions on the prescribing, distribution, sale, and advertising of drugs; and at the same time, regulators — especially anti-industry, anti-drug zealots appointed by President Obama — have imposed new criteria in addition to the demonstration of safety and efficacy (which is required by statute) in order to obtain even those limited approvals.

The consistently risk-averse Congress has granted the FDA additional powers to put in place new restrictions.

What might be considered an additional, third criterion pertains to the fda’s relatively recent emphasis on the obligations of pharmaceutical company executives to ensure the integrity of the “global manufacturing chain” of their products. In a May 20, 2008, speech, Doug Throgmorton, the deputy director of the fda’s Center for Drug Evaluation and Review, said that controlling the supply chain for quality “is a very complex problem and there are a lot of pieces in place to address,” adding that it “starts with the manufacturing sector understanding that there is an expectation on them to provide a manufactured quality product” and emphasizing yet again that “first and foremost” this is an issue of “corporate responsibility.”

What sorts of changes do such statements suggest may be required? According to a prominent attorney who was a senior fda lawyer for many years and is now in private practice, regulators will likely expect to see a more explicit, formal paper trail of control over the supply chain, extending even to third-party certification that each participant in the drug manufacturing chain is performing correctly. The manufacturer and/or marketer of the final product will then have to certify to the fda that it has verified the entire process. The attorney compared it to the onerous Sarbanes-Oxley assurances of compliance with general business practices. This sort of requirement will add yet another level of complexity (and costs) to drug development.

The fda has begun to impose what is in effect an additional, fourth criterion for approval of drugs: post-marketing studies as a condition of approval. (Whereas they were once a rarity, they are now required in more than three-quarters of approvals.)

In addition, regulators have created a new fifth criterion that could inflict significant damage on both patients and drug companies: Seemingly arbitrarily, the fda sometimes requires that new drugs be not merely effective but actually superior to existing therapies, a new standard that is often difficult and extremely costly to meet. In April 2007, the fda announced what appears to be a landmark decision. Although the law requires that in order to be marketed, a drug must simply be shown to be safe and effective, in denying approval of Merck’s new drug, Arcoxia, a cox-2 inhibitor for the relief of arthritis pain, the fda said that Arcoxia needed to be shown to be superior to existing drugs to merit approval. Robert Meyer, director of the fda office that oversees arthritis drugs, claimed that the agency’s advisory committee had sent a clear message that “simply having another drug on the market . . . didn’t seem to be sufficient reason” for approval. But whether or not the advisory committee meant to convey that (and in any case, advisory committee recommendations are not binding), it is specious reasoning.

In fact, for a variety of reasons, having “another drug on the market” that appears from clinical trials data to be no better than alternatives may be important. First, there are important differences between drugs that act through similar mechanisms: Different cox-2 inhibitors and statins, for example, were shown long after the initial approvals to have distinct and critical advantages and disadvantages; physicians can select one over another, depending on their patients. Second, if two drugs are both effective in 40 percent of patients with a given symptom or disease, it may not be known whether they work in the same 40 percent. Thus, if the drugs are effective in different patient populations, the failure of regulators to approve the second drug could deprive a large number of patients of access to an efficacious drug. At best, practitioners would have fewer choices. Third, a substantial fraction of the prescribing of many drugs is outside the primary indications specified in the original approval; these subsequent uses may be either approved or “off-label” indications. But if a drug is not approved for its initial indication because it is not sufficiently superior to a previously approved medicine, further testing might not be performed and other uses, therefore, never discovered.

Proving that a drug is better than existing drugs often is much more difficult and vastly more expensive than just proving that it is safe and effective: If two medicines’ efficacy is only marginally different, the clinical trials must be very large in order to attain statistical significance. Thus, many drugs useful for some patients will founder if the fda’s expressed new criterion is widely implemented, thereby reducing competition in the drug market and causing prices to rise. The onetime chairman and ceo of the pharmaceutical company Wyeth, Robert Essner, has described the implications of the requirement to show superiority: “If you’re the first company to get approved in a certain area and competitors can’t get on the market, the fda is now establishing monopolies. And that’s certainly not their mandate.” Whatever one thinks of regulation to ensure safety and efficacy, surely we should not have an fda that aggressively discourages competition.

Why the FDA is risk-averse

Senator charles e. Grassley once chided drug regulators: “The health and safety of the public must be the fda’s first and only concern.” He is right, but particularly when governmental pre-marketing approval of a product is required, greater health and safety are not synonymous with more stringent regulation. In fact, net benefit to patients often suffers because of an obscure regulatory phenomenon — the asymmetry of outcomes from the two types of mistakes that regulators can make. A regulator can err by permitting something bad to happen (approving a harmful product, a Type I error in risk-analysis parlance) or by preventing something good from becoming available (not approving a beneficial product, a Type II error). Both outcomes are bad for the public, but the consequences for the regulator are very different.

The first kind of error is highly visible, causing the regulators to be attacked by the media and patient groups and to be investigated by Congress. But the second kind of error — keeping a potentially important product out of consumers’ hands — is usually a nonevent and elicits little attention, let alone outrage. The fda’s approval process for new drugs has long struggled with this  Type I/Type II dichotomy. Consider, for example, the fda’s approval in 1976 of the swine flu vaccine, generally perceived to have been a Type I error, because although the vaccine was effective at preventing influenza, it would manifest a major side effect that was unknown at the time of approval — 532 cases of paralysis, including 32 deaths, from Guillain-Barré syndrome.

Type II errors caused by a regulator’s bad judgment, timidity, or anxiety seldom gain public attention.

The mistaken approval of such a product is highly visible and has immediate consequences: The media pounces, the public denounces, and Congress pronounces. The developers of the product and the regulators who allowed it to be marketed are excoriated and punished in such modern-day pillories as congressional hearings, television newsmagazines, and newspaper editorials. Because a regulatory official’s career might be damaged irreparably by the good faith but mistaken approval of a high-profile product, decisions are often made defensively — in other words, to avoid Type I errors at any cost.

Type II errors in the form of excessive governmental requirements and unreasonable decisions can delay commercialization of a new product, lessen competition to produce it, and inflate its ultimate price. The detrimental effects of fda delays in approving certain new drugs already approved in other industrialized countries are well-documented. These include the greater than three-year delay in the approval of misoprostol, a drug for the treatment of gastric bleeding, a delay that is estimated to have cost between 8,000 and 15,000 lives per year; and the lag in the approval of streptokinase for the treatment of occluded coronary arteries, which may have caused the loss of more than 10,000 lives per year. Although they can profoundly compromise public health, Type II errors caused by a regulator’s bad judgment, timidity, or anxiety seldom gain public attention. Often only the employees of the company that makes the product and a few stock market analysts and investors are likely to be aware of them.

Likewise, if a regulator’s mistake precipitates a corporate decision to abandon a product, the cause and effect are seldom connected in the public mind. The companies themselves are loath to complain publicly about fda misjudgments because the agency wields so much discretionary control over their ability to test and market products. As a consequence, there may be little direct evidence or data to document the lost societal benefits or the culpability of regulatory officials. Former fda Commissioner Alexander Schmidt aptly summarized the regulator’s conundrum: “In all our fda history, we are unable to find a single instance where a Congressional committee investigated the failure of fda to approve a new drug. But the times when hearings have been held to criticize our approval of a new drug have been so frequent that we have not been able to count them. The message to fda staff could not be clearer.”

There may be little direct evidence or data to document the culpability of regulatory officials.

As a result, regulators make decisions defensively — avoiding approvals of potentially harmful products at any cost — so they tend to delay or reject new products of all sorts, from fat substitutes to vaccines and painkillers. If a regulator does not understand or is vaguely uneasy about a new product or technology, his instinct is to delay or interdict. That’s bad for public health and for consumers’ freedom to choose.

The fda is not unique in this regard. All regulatory agencies are subject to social and political tensions that cause them to be castigated for the dangerous — or allegedly dangerous — products that make it to market but to escape blame when they keep beneficial products out of the hands of consumers. Congressional oversight is supposed to provide a check on regulators’ performance, but as observed by Schmidt, rarely does it focus on unnecessary delays of product approvals. After all, a premature or mistaken approval makes for more exciting hearings, with injured patients and their families paraded before the cameras. Even when regulators’ inappropriate delays are exposed, they can fall back on the “erring on the side of caution, better safe than sorry” defense. Too often, legislators, the media, and the public accept these euphemisms uncritically, making our system of pharmaceutical oversight progressively less accountable and less relevant to the public interest.

What’s more, the Food and Drug Administration Amendments Act (fdaaa), which took effect on March 25, 2008, gave the fda sweeping new powers, among which was the ability to require a Risk Evaluation and Mitigation Strategy (rems) for every newly approved drug. According to the fda, a rems is “a strategy to manage a known or potential serious risk associated with a drug or biological product,” which could be said to encompass virtually every medicine. The agency’s explanation continues, “A rems can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the rems.” The term “elements to assure safe use” sounds benign enough, but regulators’ demands can be so drastically restrictive as to constitute a new, distinct and limited, or conditional, class of approvals. The elements to assure safe use as defined in fdaaa may include:

  • “Health care providers who prescribe the drug have particular training or experience, or are specially certified.”
  • “Pharmacies, practitioners, or health care settings that dispense the drug are specially certified.”
  • “The drug is dispensed to patients only in certain health care settings, such as hospitals.”
  • “The drug is dispensed [only] to patients with evidence or other documentation of safe use conditions, such as laboratory test results.”
  • “Each patient using the drug is subject to certain monitoring.”
  • “Each patient using the drug is enrolled in a registry.”

All of these limits conspire to reduce the potential market for a drug. The reality is that anything that makes a drug more difficult or complicated to prescribe discourages physicians from doing so, even when it is needed.

Drug companies in critical condition

These developments constitute a devastating multiple-whammy that is dangerous for patients and debilitating to one of the nation’s most innovative and critical industries. A measure of the critical condition of the big pharmaceutical companies comes in criticism of the fda by corporate leaders. Fred Hassan, ceo of Schering-Plough, said of the current regulatory climate, “What will it take to get new drugs approved? The point is, we don’t know.” Severin Schwan, the ceo of Roche Holding ag, has predicted that some major drug companies will fail because of a lack of innovative medicines that health insurers will be willing to reimburse. Will America’s once-thriving pharmaceutical industry be the next candidate for huge federal bailouts — this time because of excessive and wrong-headed regulation? The future does look bleak: Given the profoundly anti-drug-industry, pro-regulation inclinations of the members of Congress who oversee the fda or appropriate the agency’s funding, these trends are likely to continue at least into 2011, and probably beyond.

One of the less obvious burdens imposed by the Congress on the drug industry is constantly escalating “user fees,” which drug companies must pay to the fda just to get the agency to do its job. Already more than $1.2 million for the typical drug, these fees are tantamount to a discriminatory tax on a single industrial sector — one that at great financial risk develops and makes products critical to public health (and to the reduction of health care costs). It is a tax that discriminates against small companies, which can ill-afford additional, up-front regulatory expenses, and that will inevitably be passed on to everyone who purchases a prescription drug. At a time of belt-tightening and corporate desperation, the nation doesn’t need more taxes, especially ones that are invidious, discriminatory, anti-innovative, and hidden. Members of Congress should face up to their responsibilities, appropriate whatever funds they think are necessary for the fda, and then permit the public to judge the results. User fees are a shabby attempt to fund government activities off the books.

The White House is asking not only for boosts in fda user fees, but in greater funding overall. A decade ago the agency’s budget was $1.3 billion. The fy 2010 budget was $3.2 billion, a 19 percent increase over the previous year, the largest boost in fda history. And for the next fiscal year, which begins in October 2010, the budget is expected to soar to about $4 billion, another record increase. However, aside from beefing up drug company inspections abroad and tightening food safety regulations and modest new resources for its newly mandated oversight of tobacco products, the fda does not need additional funding. In fact, there are numerous programs that could be eliminated or policies altered in ways that would save money, improve agency efficiency, and benefit public health.

Congressional cluelessness

Congressional cluelessness toward the fda was exemplified by a December 3,2008, letter from Bart Stupak, chairman of the House Commerce Committee’s Subcommittee on Oversight and Investigations, to Obama about the fda’s failings. In it, he accused the fda of having “abandoned its core mission of protecting Americans from contaminated food, unsafe drugs, and medial [sic] devices.” Moreover, he wrote that “current senior fda employees are too close with the industries they regulate, creating a question of who they are working for.”

On the contrary, as recounted in a June 30, 2008, Wall Street Journal article (“Drug Makers Say fda Safety Focus Is Slowing New-Medicine Pipeline”), companies have been “facing a tough new regulatory climate” from highly risk-averse and capricious regulators. Bringing a new drug to market now requires on average 12 to 15 years, and costs have skyrocketed to more than $1.4 billion — in no small part because of increased risk-aversion at the fda that increased the average length of a clinical trial 70 percent between 1999 and 2005. Perhaps the most ominous statistic of all is that drug manufacturers recoup their r&d costs for only one in five approved drugs. This pushes companies to try to produce blockbusters to finance less successful (or failed) drugs, but as Jeffrey Kindler, chairman and ceo of Pfizer, admitted in a recent interview, “you can’t build a company predicated on the belief that you’re going to find such” products.

Instead of checking the fda’s excesses using its dual roles of oversight and appropriations for federal agencies, the Congress has thrown gasoline on the conflagration. Representative Rosa DeLauro has proposed legislation that would establish a three-year moratorium on direct-to-consumer advertising because “we must ensure consumers know what they are getting, and drug makers know what they are promising.” This limitation on newly approved drugs — yet another element of a “limited,” or conditional, approval —  would be unnecessary and unwise; studies show that newer drugs are, on average, better at saving lives than older ones, and also that direct-to-consumer advertising induces patients to seek professional help for their illnesses earlier than they would otherwise.

A study published in October 2008 by Columbia University economist Frank Lichtenberg studied patterns in the dispensing of prescription drugs in 49 of the 50 states from 1995 to 2004, thereby examining whether prescription drugs have helped to reduce the growth in disability rates. Lichtenberg found a significant relationship between disability rates and how long ago drugs were approved. Specifically, he concluded that “if people used the same drugs in 2004 that they had used in 1995,” disability rates would have increased far more than they actually did, and about 418,000 more working-age Americans would have needed Social Security Disability Insurance in 2004, at an additional cost to taxpayers of $4.5 billion.

Cowed by pressure from congress and the fda and relentless bashing by anti-corporate activists, in June 2007 Merck, Schering-Plough, Johnson & Johnson, and Pfizer announced a moratorium on direct-to-consumer ads for new drugs, and they volunteered to limit how they would use doctors in their ads. This moratorium on advertising is only the beginning of what will likely be a long period of debilitating and degrading capitulation to anti-innovative, anti-patient ideas and policies. There is nothing on the horizon that can slow the regulatory juggernaut. A lengthy delay in a drug’s approval or its abandonment because of excessive regulation is, after all, a nonevent, while allegations of side effects and litigation against drug companies are front-page news.

No help from the top

The obama administration has appointed new leaders at the fda who have made the agency’s problems palpably worse. In fact, they are unwilling even to acknowledge them. One of the first actions of new Commissioner Margaret A. Hamburg was to form a task force to develop recommendations for “enhancing the transparency of the agency’s operations and decision-making process,” in order that the fda can “make more available, useful, and understandable information on its activities and decisions.” In other words, it’s not the quality of policies and decision-making that are the problem; it’s merely the way that they are communicated.

Every generation of fda leadership seems to have a different explanation for the escalating costs and falling output of drug r&d — but none blames the agency in any substantive way. During the administration of George W. Bush, the party line was that if only drug companies had a better understanding of the fda’s requirements, things would surely improve. Health and Human Services Secretary Kathleen Sebelius, a former governor, has no prior experience or expertise with any of the functions or missions of the fda. Unfortunately, that cannot be said of Deputy hhs Secretary Bill Corr, a former senior staffer to former hhs Secretary Donna Shalala in the Clinton administration and, before this current appointment, executive director of the Campaign for Tobacco-Free Kids. He has long lobbied for additional authority and power for the fda, including a mandate to regulate tobacco products.

Likewise, the previous experience of Dr. Joshua Sharfstein, the principal deputy commissioner, is no asset. Given the fda’s current problems, Sharfstein is an incomprehensibly bad choice to serve as what is in effect the agency’s chief operating officer. He has a long history of hostility toward the pharmaceutical industry. While a medical student at Harvard, he led a student campaign urging classmates to return textbooks donated by a pharmaceutical company. According to the university’s newspaper, Sharfstein and his group alleged that the texts “are paid for by consumers in the form of higher drug prices. Accepting gifts from companies violates an ethical obligation to our future patients.” They set up a drop-box, where, like a gun amnesty program, students were urged to return the books. (The project failed. Apparently, most of Sharfstein’s classmates were less radical than he.) He went on to work as health policy advisor to Democratic Representative Henry Waxman of California, who personifies the divisive approach that castigates and persecutes innovative pharmaceutical companies; and for Sidney Wolfe, anti-drug and anti-industry zealot extraordinaire.

Sharfstein’s malign influence is already evident in a number of ways. He attempted to block importation of “electronic cigarettes,” an important aid to cessation of smoking, but was enjoined from doing so by the federal courts; he reversed a sound, existing policy that required prior legal counsel review of “regulatory letters,” such as warnings, sent to companies; and he has cranked up the stringency of regulation of medical devices (including pacemakers, artificial joints, and cardiac stents) to an extent that threatens innovation in the industry.  

The list goes on.  In March 2010, the fda asked pediatricians to stop administering Rotarix, a vaccine that prevents rotavirus infection, a diarrheal illness that can cause severe dehydration. The rationale was that small amounts of dna from a pig virus have been detected in the vaccine preparation. That might sound like a good reason for concern — except that the fda itself confirms “that the material has been present since the early stages of product development, including during clinical studies.” In other words, all of the studies that confirmed the safety and efficacy of the vaccine were performed with the viral dna present. And the fda continues to believe that “Extensive studies, including placebo-controlled, randomized clinical studies involving tens of thousands of vaccine recipients, support the safety and effectiveness of the vaccine.”  Margaret Hamburg said, “We’re not taking this action on the basis of a safety concern.” Moreover, the virus is commonly consumed in pork products and does not cause disease in any known host, including humans. One must wonder, then, what is the problem that the fda is trying to fix by interrupting the use of this vaccine?

Last year, Chicago federal appellate judge Richard Posner blasted the government for bringing a case against a salad dressing wholesaler who had changed the labels on more than a million bottles of salad dressing to extend their shelf life. Posner found that not only was there nothing in food law about “best when purchased by” dates but that there was little likelihood of endangerment of public health. No harm, no foul. Moreover, he said, “the testimony of the fda’s employee was not just improper and inadmissible but incoherent.”

Also of concern are many of the other political appointments to the fda (of which there are only a handful, far fewer than at most federal agencies). They include:

  • Ralph S. Tyler, newly appointed general counsel, whose main qualification seems to be his acquaintance with Sharfstein. This is a position that demands an independent, smart lawyer who is highly knowledgeable about food and drug law, but Tyler’s last job was insurance commissioner of Maryland, and he lacks any experience with fda-related legal issues.
  • Peter Lurie, senior policy advisor, who was previously at the anti-drug, anti-industry group Public Citizen. Someone with similarly strong pro-industry views would not be considered an acceptable appointment.
  • Lynn Goldman, fdascience advisor. While a senior epa official in the Clinton administration, Goldman never met a regulation she didn’t like and oversaw extremely radical, unscientific policy- and decision-making, especially regarding chemicals and biotechnology. She grossly misrepresented agency biotechnology policy in published statements. At the fda, she has resumed the battle against chemicals that she conducted at the epa; her first target is an important component of certain plastics called bpa.

Yet another reason for pessimism is the influence of important White House advisors, such as Obama transition team co-director John Podesta, who do not currently serve in positions within the government. In 2007, the Center for American Progress, headed by Podesta, proposed changes in regulation that would only worsen the agency’s existing problems by lengthening the time required to develop a drug and further increasing r&d costs. Its report, “Prescriptions for Drug Safety,” is a prescription for additional obstacles to U.S. drug development.

At a time when the U.S. population is aging and needs innovative new medicines for a wide spectrum of degenerative and infectious diseases, these developments are not what the doctor ordered.

Realistic reforms

I have previously proposed a variety of reforms of the way drug development is regulated, but now is not the time to suggest major changes. The pendulum is currently swinging toward more stultifying regulation, so for the foreseeable future only relatively moderate changes that will improve the existing fda have even the remotest chance of being enacted. Here are several such:

  • The fda’s Drug Watch program has more to do with public relations than public health. According to the agency, the program simply makes “emerging safety information” about medicines publicly available before the fda has “fully determined its significance.” Drug Watch is “not intended to be a list of drugs that are particularly risky or dangerous for use; listing of a drug on Drug Watch should not be construed as a statement by fda that the drug is dangerous or that it is inappropriate for use.” It is difficult to predict what physicians and other health care providers — let alone members of the public — will do with such preliminary data, which are available on the fda’s web site. There is a difference between indiscriminate data and useful information, and the Drug Watch Program seems destined to provide far more of the former than the latter. It should be reevaluated.
  • 2008 memorandum of agreement between two groups within the fda’s Center for Drug Evaluation and Research is systematically slowing drug development and increasing its costs. Under the accord, the drug review and drug safety offices will have equal responsibility for “significant safety issues” pertaining to medicines that are under review or have already been approved for marketing. Officials in the latter group are focused so narrowly on “safety” that they ignore the fact that because all drugs have side effects, safety cannot be evaluated in a vacuum but must be part of a risk-benefit judgment. The drug-safety zealots should be returned to a purely advisory role. Reviews would proceed more efficiently, scientifically, and expeditiously.
  • The fda announced in 2007 a plan to perform a comprehensive assessment of the safety of some new drugs within 18 months of their introduction and to issue a sort of report card on their performance. Although this may sound plausible, it is inconsistent with data showing that, in fact, newer drugs confer an advantage over older ones in reducing mortality. In a study of patients who took drugs between January 2000 and June 2000, those who took newer medications were less likely to die by the end of2002. The estimated mortality rates were directly related to time that had elapsed since approval of the drugs: For pre-1970 drugs, the estimated mortality rate was 4.4 percent, while the mortality rates for drugs approved during the 1970s, 1980s, and 1990s were 3.6 percent, 3.0 percent, and 2.5 percent, respectively. This plan is another candidate for elimination, or it could be limited to only very widely prescribed drugs whose clinical trials raised safety concerns.
  • Most day-to-day evaluations and approvals of drugs, medical devices, and food products are performed quite autonomously within the fda’s various decentralized units. And yet there are massive, largely superfluous bureaucracies that serve the commissioner and a horde of deputy commissioners, associate commissioners, and assistant commissioners. These should be trimmed drastically, freeing resources for the agency’s essential programs, in lieu of massive increases in appropriated funds and user fees.
  • In 2007, the fda introduced new restrictions on members of advisory committees, which are comprised of outside experts. Committee members who receive money from makers of drugs or medical devices are now barred from voting on whether to approve that company’s products; and if they receive more than $50,000 from a company whose product (or whose competitors’ products) is under discussion, they would no longer be allowed to serve on the committees. This eliminates those experts who are likely to possess the greatest expertise about the subjects under discussion, the bona fide elite of the research community. Disclosure of potential conflicts of interest and recusal when appropriate would be far better than the current, rigid, one-size-fits-all automatic exclusions and disqualifications.
  • As the result of a policy announced in 2009, the fda requires that every new genetic construction in an animal that employs gene-splicing technology undergo evaluation under the same procedures and regulations as those for drugs used to treat animal diseases. In other words, the genetically altered animal would be treated as though it were a new drug. A more apposite model for evaluating gene-spliced animals would be the agency’s methods of oversight of traditional foods and food additives; of “natural mutants”; and of livestock clones, or identical twins, which fda has decided are safe to eat. This approach would ensure food safety but would be far less labor- and time-intensive for fda personnel.
  • Many fda evaluations take far longer than they should. These include approvals of new drugs, vaccines, medical devices (such as artificial joints and pacemakers), and food additives. Not only is there minimal accountability for dilatory performance, but the agency’s pervasive risk-aversion actually rewards anti-drug bias. Greater accountability, more expeditious decision-making, and improved risk-benefit balancing would expend existing and additional resources more efficiently.
  • The fda’s senior management must act as a buffer between ideological, no-amount-of-regulation-is-ever-enough critics of the agency (in Congress and elsewhere) and the staff who make must make day-to-day decisions.
  • The current fda leadership has permitted self-styled whistleblowers to flout the agency’s ethics rules by publicly contradicting agency policy and disparaging drugs and drug companies that they dislike. More-disciplined management would boost morale and increase productivity.

Former fda Commissioner Andrew von Eschenbach once said that the fda should be “a bridge to the future, not a barrier to the future.” If only the current fda leadership and their political masters felt that way.