Our Views

A Colorado bill will prevent health insurers from offering incentives to doctors to prescribe cheaper generics rather than Big Pharma’s pricier brands.

An interesting development in the ongoing pharmaceutical doctor-bribing drama across the country is taking place in Colorado, where a bill is pending approval that bans health insurers from providing incentives (read “payola”) to doctors to switch patients’ drugs from more expensive brand names to cheaper generics.

Sen. Paula Sandoval, (D-Denver), sponsoring the Colorado bill, told Associated Press that a patient’s health should be a doctor’s primary concern. “There shouldn’t be any financial incentive interfering with that decision,” she said, adding that there have been reports of kickbacks from insurance companies and lawsuit settlements in other states, and the new bill would ensure it doesn’t happen in Colorado.

Of course, Kaiser Permanente, along with major insurance players AARP and the insurance industry’s Colorado Association of Health Plans, all oppose the bill. These are the folks who write the checks for brand-name prescriptions. More generics save them a bundle.

But believe it or not, major Big Pharma player Pfizer Inc., which ranks number one in the world in sales, was actively involved in helping Colorado’s medical society shape the bill. If doctors were to prescribe more generic replacements for Pfizer’s blockbuster cholesterol drug Lipitor, for example, which cranks out a whopping $13.5 billion in annual sales and accounts for nearly a third of Pfizer’s revenue and 40 percent of its profit, it could inflict serious damage.

We don’t need to ask why Pfizer has taken an interest in this bill. What we need to ask is why the state of Colorado and Sen. Sandoval in particular have brought in, or even allowed, an individual Big Pharma corporation with billions at stake to help draft a bill that keeps the billions rolling in?

That’s just inviting the fox in to help design the hen-house fence.

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Suit alleges the pharmaceutical giants violated state consumer protection laws and federal and state antitrust laws by delaying availability of cheaper, generic versions through trickery or deception.

Florida and Massachusetts are among 26 other states that are joined in an antitrust lawsuit against pharmaceutical companies for allegedly blocking access to cheaper drugs, costing the states millions of dollars in .

The suit alleges that Illinois-based Abbott Laboratories and French drug companies Fournier Industrie et Sante and Laboratoires Fournier, S.A., violated state consumer protection laws and federal and state antitrust laws by delaying availability of cheaper, generic versions of TriCor, a cholesterol lowering drug that last year accounted for more than $1 billion of Abbott’s sales.

The states’ complaint seeks relief in the amount of three times the amount of overcharges paid by states and consumers for TriCor, plus costs and civil penalties.  The states are also seeking injunctive relief, prohibiting Abbott and Fournier from engaging in similar anticompetitive practices in the future.

The states allege in U.S. District Court in Wilmington that the companies continuously made minor changes in the formulation of TriCor to prevent cheaper generic versions from being marketed. The complaint seeks triple the amount of damages incurred by the states’ public health agencies and individual consumers.

Ed Silverman in his Pharmalot blog reports that Abbott spokeswoman Melissa Brotz told the Associated Press that the company’s actions were lawful, that Abbott hasn’t prevented the marketing of drugs similar to TriCor, and that there are eight other products already available. Neil Hirsch, a spokesman for Fournier’s parent Solvay, told the AP Fournier hasn’t engaged in any wrongdoing and intends to vigorously defend itself against the allegations.

But Maryland Attorney General Doug Gansler said Abbott and Fournier obtained patents protecting TriCor from competition by deceiving the U.S. Patent Office with incomplete and misleading data. And Florida Attorney General Bill McCollum said Florida’s growing senior population faces ever increasing costs of prescription drugs, and the state “cannot permit drug companies to edge out competition and potentially less expensive generic alternatives.”

The states joining Massachusetts in the investigation and prosecution of this action against Abbott and Fournier are:  Florida, Arizona, Arkansas, California, Connecticut, Idaho, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New York, North Carolina, Ohio, Oregon, South Carolina, Texas, Vermont, Washington, West Virginia, Pennsylvania, and the District of Columbia.

Big Pharma’s obsession with profits at any cost is threatening to destroy what was once the envy of the world—the United States medical system.

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Lawmakers in Massachusetts have decided they’ve had enough of Big Pharma “bribing” physicians, and if a new bill becomes law, allows fines of up to $5,000 for even offering a gift.

The Massachusetts state Senate has approved a bill containing a sweeping package of reforms it hopes will control skyrocketing health-care costs. Among other measures, the bill bans Big Pharma from giving gifts of any value to physicians and health care facilities.

The state’s doctor-gift provision may get Big Pharma’s attention, since it has the teeth that were missing in a federal bill proposed recently by Herb Kohl (D., WI), and Chuck Grassley (R., IA), which we discussed recently in Our Views, requiring Big Pharma only to report all payments and gifts made to physicians. Massachusetts first-of-its-kind bill actually sets fines of up to $5,000 for Pharma or device marketers who “offer or give to a physician, a member of a physician’s immediate family, a physician’s employee or agent, a healthcare facility or employee or agent of a healthcare facility, a gift of any value.”

An earlier version of the bill made such gifts a crime, but the criminal clause was removed from the final version. Before taking effect, the bill must pass the state House of Representatives and be signed by Governor Deval Patrick.

Reaction from the industry has been predictably noisy, including an op-ed piece in the Boston Herald by two notable physicians, Dr. Thomas Stossel of Harvard and his colleague, Dr. Dennis Ausiello, who decry the bill as a really bad idea. But as Dr. Howard Brody points out in his blog Hooked, Ausiello is a director at Pfizer and Stossel is a paid consultant to Merck, with each having several other major interests as well. What else are they going to say?

Banning pharma gifts is a trend, not some solitary new idea

The writing is on the wall. Gifts from Big Pharma and its device-making counterparts may soon be unwelcome at all 129 of the nation’s medical colleges, according to a new report from the Association of American Medical Colleges, which spent two years on the project. Also, according to The Prescription Project, in 2007 over half of all state legislatures considered bills addressing various aspects of bribery-based pharmaceutical marketing, and more of them will soon follow suit. In Minnesota, gifts worth more than $50 are banned already, and Vermont requires public disclosure of gifts over $25.

Not only that, many academic medical centers have banned drug company gifts, including Yale, Stanford, University of Michigan, University of Pennsylvania, Boston Medical Center, Vanderbilt University, University of Pittsburg, and University of Massachusetts. And the University of California will soon follow with its gift ban.

Of course, banning gifts is only the first step to putting integrity back into our medical system. As long as academic medical centers continue to rely on huge “grants” from Big Pharma to fund medical research, the “results” will never truly be independent. As long as most of the continuing medical education available to doctors is funded by drug companies who promote their products then doctors will not really receive unbiased information.

Although we’d liked to have seen the criminal felony clause retained in the bill, the $5000 fine for even offering a gift is a start. We hope the House and the Governor approves it. Hitting Big Pharma in the pocket book may be the only thing this industry understands. Big Pharma should just knock off the bribery. If their products really work they will be purchased—just like any other product.

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FDA’s letter to GSK warns Big Pharma to get its act together and start reporting all adverse event information or suffer the consequences of fines and criminal proceedings.

In his In Vivo blog, Micheal McCaughan suggests that the warning letter sent to GlaxoSmithKline (GSK) about its diabetes drug Avandia is more than just bad news for the company, but a warning for other biopharmaceutical companies as well.

After inspecting the firm’s post-market adverse event reporting procedures and discovering that GSK has not filed all the necessary reports on Avandia, the FDA issued a strongly worded letter, addressed to the firm’s CEO Jean-Pierre Garnier. Since the Food, Drug and Cosmetics act is a “strict liability” statute, top executives — starting with the CEO — can be held criminally accountable for violations they knew nothing about.

McCaughan says this is the key section in the letter:

FDA’s inspection revealed that your firm lacked appropriate knowledge of the studies associated with Avandia, resulting in the reporting deficiencies noted. Absent a clear explanation of the extent and cause of these deficiencies and an adequate plan to correct them, we are concerned that similar deficiencies in the postmarket reporting for your firm’s other FDA-approved drugs may exist . We expect that your corrective actions will include a comprehensive evaluation of your firm’s reporting of postmarketing studies for all drug products for which your firm holds an approved application.

McCaughan goes on to say: “The warning letter should be a must read for all biopharma companies with products on the market (and all companies who hope to be so lucky as to have products some day). The letter does indeed add to GSK’s headaches, but for the rest of the industry it should serve as notice that the agency is likely to do a lot more enforcement of postmarketing study reporting requirements in the months and years ahead.

“Congress, remember, has just handed FDA new enforcement authority over postmarketing trials, in the form of the ability to mandate Phase IV studies — and fine sponsors who fail to live up to their commitments.

“In the new world of post-marketing oversight and regulation,” he adds, “expect the agency to make sure that every company gets that message loud and clear.”

Post-marketing adverse events are what we, the public, are all too familiar with. That’s when we usually hear about drug problems — headlines citing injuries, deaths and massive lawsuits, or worse, learning that someone we know or love is a victim.

The FDA’s record on ensuring that prerelease drug testing is thoroughly done before drugs reach the market has been less than stellar in recent years. Many clinical trials showing that a drug had problems were kept from the FDA and the public. Most new drugs are released on the public after being tested with less than 1000 to 3000 carefully chosen patients. This is why the FDA admits that the real tests of a new drug only occur after their release to the public and is why post-marketing disclosures are so important.

That is why it is so critical that post-marketing adverse effects are reported promptly. But post-marketing muscle has been flabby as well, with drugs causing hundreds or even thousands of adverse events before the FDA acts.

Post-marketing inspection and reporting is at least as important as prerelease clinical trials and testing, because no program can possibly cover every possible scenario that could and will exist in the real world. Post-marketing vigilance is critical, and we’re glad to see the FDA stepping up to the plate to get the attention of Big Pharma, and exercising the new muscle given to it by Congress last year in changes to the FD&C Act.
We just hope that the FDA is not just making a show but are serious about this and will take affirmative action if GSK doesn’t immediately correct the problem.

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Whistle-blower lawsuit alleges Schering-Plough failed to reveal problems with a drug that killed five people, including two children, and seriously injured 53 others.

Schering-Plough recently spent $14.3 billion to buy the drug company Organon, and now must face allegations that serious “adverse events” associated with Organon’s neuromuscular blocking agent Raplon were not disclosed before or after FDA approval back in 1999. After five people died, including two children, and at least 53 others suffered severe bronchospasm, Organon withdrew Raplon from the market in March 2001.

Raplon was designed to paralyze a patient’s throat to facilitate intubation — inserting a breathing tube into the trachea — and claimed to induce paralysis faster than older generic drugs that cost less than $1 per unit compared with $20 for a unit of Raplon. Problems arose when patients receiving Raplon suffered serious bronchospasms that stopped their breathing.

According to Ed Silverstein’s Pharmalot blog on the subject, the Raplon problems occurred when Schering-Plough’s senior vp for global fertility, Hans Vemer, was still the top man over at Organon. The whistle-blower, Jeff Feldstein, a former Organon employee, first filed his charges in 2002, about the same time he filed a wrongful termination lawsuit against Organon. The US Attorney in Boston declined to join the whistleblower charges at that time, so Feldstein now is pursuing the case independently.

Feldstein’s lawsuit in federal court in New Jersey alleges that Organon executives knew of the serious problems with Raplon and instead withheld the evidence from the FDA in order to get approval. As well as failure to disclose, Feldstein also claims that Organon’s behavior caused false claims to be submitted to Medicaid and Medicare.

Schering-Plough, of course, vehemently denies the charges, saying it will “vigorously defend Organon”. However, the evidence offered by the suit, including copies of internal memos, strongly suggests that Organon ignored the warning bells expressed by clinical investigators prior to the drug’s launch.

If it is determined that Organon did fail to disclose to the FDA its concerns about bronchospasm, it will be yet another blow to Schering-Plough, already suffering from its partnership with Merck over the Vytorin and Zetia debacle. Then there’s the $435 million settlement in 2006 for federal civil and criminal charges that it illegally promoted several drugs for off-label use, and defrauded Medicaid — the third such settlement for Schering in just two years. Schering Sales pled guilty to one count of conspiracy for making false statements to the government and paid a $180 million criminal fine as well.

So, yes, the FDA has some changes to make to prevent these kinds of situations, and they need to do it fast. New policies are needed to jolt Big Pharma enough to wake up and smell the fire and brimstone. It’s time for new business models, both at the FDA and for Big Pharma.

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Merck and Schering-Plough are not the only Big Pharma players getting hurt by their own actions.

Before Merck and Co. withdrew the painkiller Vioxx in 2004, it was linked to tens of thousands of heart attacks. Now a new study of internal Merck documents alleges the company knew of the dangers years earlier, but falsified statistics to hide them from the FDA.

In the five years it was on the market, Vioxx was a blockbuster for Merck that generated billions of dollars. When it was eventually linked to heart attacks and strokes, the product was pulled from the market. Earlier this year, Merck agreed to almost $5 billion in compensation to the victims of the Vioxx — I hesitate to use it, but there’s just no other word to describe it — scam.

A scam is “a confidence game or other fraudulent scheme, especially for making a quick profit.” A popular synonym is the word “swindle”. And that’s exactly what Merck, a Big Pharma player, worked on its millions of patients, their physicians, and before that, the Food and Drug Administration that approved the drug.

Now Merck is embroiled in another possible scam, this one over its massively profitable — $5.1 billion in 2007 — cholesterol drug Vytorin, a combination of Merck’s Zocor and Schering-Plough Corp.’s newer drug Zetia. An ongoing study shows that Vytorin is no more effective than cheaper, generic versions of the statin drug Zocor at reducing plaque buildup. The report has doctors nationwide reverting to older, cheaper statin drugs. And Congress is investigating whether the two companies withheld the unfavorable study results to boost sales.

In spite of widespread public concerns about the FDA’s effectiveness at protecting us from drug dangers, the agency appears to be stepping up to plate with Merck.

The FDA has rejected Merck’s application to sell the cholesterol drug Mevacor over the counter, and it has begun an investigation into the asthma and allergy drug Singulair, linking it to higher rates of suicide. Merck had already updated the drug’s warning label about side effects including tremors, anxiousness, depression and suicidal behavior, but further investigation may reveal more problems.

Merck shares fell 35 percent in the first quarter, much of the loss due to the Vioxx scandal, according to Wall Street analysts. The company is far from the only Big Pharma player in trouble, as scams, swindles and scandals continue to surface across the playing field. According to Ed Silverman in his Pharmalot blog, Schering-Plough’s share prices have been “ravaged” by the Vytorin controversy, caused “massive layoffs”, and in general “sullied the company’s reputation.”

Well, as the old saying goes, if the shoe fits . . .

There are plenty of laws on the books, at all levels of government, designed to protect the public from scams and swindles. It’s time for our lawmakers to take a very long hard look at how Big Pharma is being regulated and its products are tested and approved. And part of the scrutiny needs to be directed at the FDA itself. A lot of people need reassurance that the scams aren’t getting some help from Big Pharma friends on the inside.

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Big Pharma’s ethics also need a major overhaul or the industry will go the way of the dinosaur.

The Journal of the American Medical Association (JAMA) reported this week that Merck and Co. faked reports on Vioxx. In other words, Merck employees wrote the reports, then attributed the articles to academic investigators hired and paid by the company to use their names.

Now that the JAMA report has made national news, all sorts of industry insiders are coming out of the woodwork and saying it’s common knowledge that Big Pharma hires ghost-writers — pays for the use of academic names — for research and development reports.

For example, in the In The Pipeline blog this week, Derek Lowe says there’s little doubt that the practice goes on. “I’ve never been in a position to see it happen, but it’s been reported for years,” he says.

Lowe points out that no one is suggesting the articles contain bad science or that conclusions drawn in them are faked, even if they written by Merck people.

“I haven’t seen anyone suggesting that the Merck studies themselves are bogus – they had damn well better not be – but by playing games with the external author list, the company invites suspicion,” Lowe says. The practice is driven by what he suggests is a need to bolster a drug’s image because of the money involved. Developing a new drug and shepherding it to market is enormously expensive.

Lowe gets close to the truth when he concludes that the only way to win back public trust, which he says “we’ve lost, in case anyone hasn’t noticed”, is to cut out the shortcuts and double-talk and “act as if what we’re doing — drug discovery — is something to be proud of.”

Calling for ethical changes in Big Pharma’s approach to its business is right on the money. But Lowe shows a lot of altruistic optimism when he says if such practices aren’t curtailed, the industry could face serious price controls, lots and lots of marketing restrictions, the FDA raising the bar for approvals to never-before-seen levels, and “flocks of lawyers beating their wings, circling around our every move” — as if Big Pharma can, on its own, accomplish the fundamental changes it needs to make.

Seeing as Big Pharma’s shady practices are so ingrained and so widespread, it seems to me that one of the measures Lowe warns of — the FDA revamping its approvals process and raising the bar – will almost certainly not be enough incentive to get Big Pharma’s ethics levels demonstrably high enough to warrant a return of public trust.

And while we’re talking about public trust, let’s face the flip side. The FDA itself has a long way to go in that department, too. The public wouldn’t be forced to resort to lawyers and the legal system if the FDA was really on the job.

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It’s been more than two years since FDA scientist David Graham told a Senate panel that the FDA was “incapable of protecting America against another Vioxx.” Now he tells a House panel that “nothing has really changed.”

20-year veteran FDA scientist told the House Subcommittee on Oversight and Investigation recently that the FDA is “incapable of protecting America against another Vioxx, and that since then nothing has really changed” in the FDA’s approvals process.

The subcommittee, chaired by Bart Stupak (D-MI), has been engaged in a series of hearings to evaluate the FDA’s ability to safely approve new drugs and provide post-marketing surveillance, with a jaundiced eye aimed at Big Pharma as well. The hearing was titled: “Ketek Clinical Study Fraud: What Did Aventis Know?”

Dr. David Graham told panel members that the FDA’s Center for Drug Evaluation and Research (CDER) “regards industry as the agency’s main client” rather than considering broad public safety as its mandate. It was Graham’s testimony in 2004 that helped lead to Merck’s arthritis drug Vioxx being pulled off the market in September of that year. Asked about other drugs that the FDA has mishandled, Graham told the subcommittee that atypical anti-psychotic medications to sedate nursing home residents kill roughly 15,000 people a year, and that the weight gain and diabetes dangers posed by Zyprexa, used to treat schizophrenia and bipolar disorder, was known for years to Eli Lilly, the drug’s maker.

Another physician, Dr. David Ross, who has worked on the CDER’s pre-approval side for a decade, said that the antibiotic Ketek, made by Sanofi Aventis, was approved in spite of the fact that the FDA knew it could “kill people from liver damage and that tens of millions of people would be exposed to it.” Ross testified that his FDA bosses forced him to ease back on his unfavorable review of Ketek.

The antibiotic Ketek, approved in April 2004, has been linked to liver failure and other adverse side effects, and the FDA announced in February that Ketek was no longer approved to treat sinusitis or bronchitis because its potential risks outweigh any benefits for these fairly benign conditions. It remains on the market to treat only pneumonia acquired outside a hospital or nursing home.

Mark Senak in his EyeOnFDA blog says the FDA is “in the stew”, and that the FDA leadership “may not believe that they are running for office. They are mistaken. They are running for an office called public confidence. And right now, as for the past few years, the agency is losing that essential race.”

Clearly there are problems with the FDA’s approvals policies and post-marketing controls. When you add Big Pharma’s propensity for unethical practices into the mix, such as withholding or altering clinical trial data, there is no question but to bring about serious changes in the way drugs are tested, reported and approved for public use.

Anything else continues the betrayal of public trust.

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“Pharmaceutical representatives often confuse educating with selling, and evidence shows that doctors’ prescribing patterns can be heavily influenced by these sales representatives.” (Senator Herb Kohl, D., Wis.)

There are few people who want to see an end to Big Pharma’s massive sales force more than Big Pharma leaders themselves. In his blog, Life Sciences Chronicle, more than 6 months ago, and again a few weeks ago in MedTech Futures, a regular feature at MidwestBusiness.com, industry watcher Dr. Ogan Gurel echoed Big Pharma’s concerns that the sales program is simply unsustainable.

“From direct personal experience,” Dr. Gurel says, “I know that many top pharmaceutical executives are keenly interested in solutions to the problem rather than sustaining what is ultimately an unsustainable arms race.” Big Pharma wants to get back to the business of bringing innovative medicines to the public, he says, rather than trying to sustain massive sales teams.

Created to promote prescription drugs to physicians, the sales rep program has bloated to an estimated cost of $20-billion-a-year and 100,000 sales reps knocking on doctors’ doors day in and day out across the country. Its value to the industry is in serious question by everyone concerned.

Herb Kohl (D., Wisconsin), chairman of the Senate Special Committee on Aging, along with Sen. Chuck Grassley (R., Iowa), recently introduced a bill requiring Big Pharma to report all payments and gifts made to physicians. News reports said some Big Pharma companies welcomed the idea, and at least one was already doing so.

But things could get worse, rather than better, if a proposal for federal grants to counter Big Pharma’s sales efforts are approved. This past March, Sen. Kohl said he and Sen. Richard Durbin (D., Illinois) would introduce legislation to encourage “counter-detailing” grant programs.

Counter-detailing, or “academic detailing”, is the name for efforts, often made by medical insurers, to counter Big Pharma’s sales pitches, including its massive sales rep program which is referred to as “detailing.” Counter-detailing pushes doctors and patients toward cheaper generic drugs, and even tries to discredit Big Pharma’s claims about their more expensive branded products.

The grant programs would help create training materials informing physicians about safety issues and comparative effectiveness of different medications, and send trained health care professionals to physicians’ offices to provide the information to physicians.

These ideas could be worse than doing nothing at all. Government-subsidized attacks on Big Pharma brands would hit Big Pharma right in the pocket-book, resulting in even more money poured into its sales forces to compete. There seems little chance that the government’s counter-detailing would support branded products, helping Big Pharma ease up on its sales forces.

Neither of the Kohl-backed bills does anything to effectively replace the bloated and unsustainable drug-rep business model with a viable alternative — one that actually informs physicians about the efficacies and safety issues of both generic drugs and Big Pharma’s branded products (without all the expensive baloney of the sales rep program) while increasing real and predictable patient safety.

What’s needed, and where the government should put its money, is into rebuilding the FDA’s approvals and aftermarket safety programs with sensible and effective policies that help Big Pharma to get more innovative drugs into the pipeline, providing the kind of thoroughly tested and ethically marketed drugs that people need, want, expect and, by their recent actions in the courts of America, are now loudly demanding.

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Reacting to reports of deaths, injuries and continuing law suits due to prescription drugs, Rep. Rosa DeLauro, D-Conn., is calling for major improvements to the drug review system at the Food and Drug Administration.

Congresswoman Rosa DeLauro, D-Conn, plans to use her clout as chairwoman of the House appropriations panel responsible for FDA funding, to improve drug safety — and it’s about time someone took the situation seriously.

Calling top agency officials simply “incompetent” over the recent crisis involving the blood-thinner drug heparin in which at least 19 people have died, DeLauro said real change can occur only with a new administration.

DeLauro was quoted in the media saying the FDA “is an agency that is charged with safeguarding the public health, but it’s being run like the keystone cops.”

In the heparin crisis, caused by contaminated ingredients from a Chinese factory, the FDA became aware of the problem only after hundreds were sickened and deaths had occurred. Of course, Congress announced an investigation.

This whole affair shows how little has changed at the agency in nearly a decade. In 1999, a contaminated antibiotic manufactured in China killed at least 17 people before the FDA took notice, and, as usual, Congress investigated. Ho-hum.

Mark Senak, commenting in a recent blog on the terrible first quarter the FDA is having, included DeLauro’s “Keystone cops” quote as one of the indications of trouble at the agency — a heavily funded, understaffed and apparently under-talented federal agency who’s single mandate is to protect the health of Americans, a job it is failing to do effectively enough.

The FDA has itself admitted it violated policy by failing to inspect the plant in China. But according to a New York Times report, drugs imported from China have soared since the last China drug scandal, while the FDA’s inspections of overseas drug plants have dropped significantly. Of the 566 plants in China that export drugs to the US, the agency inspected only 13 of them last year. The story is the same in India and other countries that make drugs or drug components for Big Pharma.

Last week Congress called on the FDA to move faster in forcing drug companies to include in their “direct-to-consumer” advertisements that flood TV every night ways for consumers to report drug side effects to the FDA. The agency tracks so-called “adverse drug events” — meaning drug side effects — and uses reports from doctors and patients to address safety problems with drugs already on the market. But because the system is voluntary, agency scientists complain, it misses the vast majority of drug reactions that occur.

“When only a fraction of adverse drug reactions are reported to the FDA, that means the system is failing,” DeLauro said. She stated her priorities are: Improving the FDA’s handling of post-market drug safety reviews; direct-to-consumer advertising; sufficient funding for generic drug reviews; addressing the agency’s advisory committee conflict of interest policies; improving device oversight; handling drug importation; and renewal of agency user fees.

Let’s keep our fingers crossed that DeLauro and company remain in place through and after this November’s election.

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