The FDA's Weak New Drug Quality Office

The FDA's Weak New Drug Quality Office

After more than two years of deliberation, the FDA has finally launched a new Office of Pharmaceutical Quality to standardize, centralize, and improve the agency's efforts to safeguard America's supply of medicines.

It is a real pity, then, that the new office is crippled from the beginning. There are no plans to publicize the data collected, so physicians and patients will remain in the dark, unsure of the true quality of the medicines they prescribe or ingest. The new office merely amounts to bureaucracy as usual, just under another name.

I hope I'm wrong. But the fact is that FDA has presided over lapse after lapse on drug quality in the past decade, opaque to the public, hostile to critics in the medical community, lacking access to combat the biggest offenders -- namely Indian pharmaceutical companies -- and firewalled from any real consequences for its failures.

Less than two years ago, Ranbaxy Laboratories, one of the largest Indian generic-drug manufacturers, pled guilty to seven felonies for deliberately masking the production and sale of substandard medicines and paid a record $500 million fine. In the time since, another half-dozen Indian companies have admitted major problems with processes and data quality and numerous product withdrawals.

In 2014, Dr. Reddy's Laboratories, the largest Indian drug manufacturer, recalled 13,500 bottles of a blood-pressure drug due to problems with pill solubility. Wockhardt, another leader Indian manufacturer, recalled 110,000 bottles of the same blood-pressure medicine for the same reason. Bloomberg News revealed that a lab technician at an Indian research facility run by Sun Pharma deleted negative testing data for a major drug line. The medicine was ultimately cleared and sent to America.

FDA inspections did uncover some of these problems -- but the agency was initially alerted to the worst of them by whistleblowers. Worse still, the agency has ignored many efforts by credible whistleblowers to sound the alarm on certain FDA-approved medicines. For example, medications that have a time-delay mechanism (such as the antidepressant budeprion) or a narrow therapeutic window (such as the transplant medication cyclosporin) can pass current FDA standards and still not work properly.

Joe Graedon of the People's Pharmacy website and radio show has been receiving complaints about these types of medications for years; antidepressants that don't stop people feeling suicidal are just the most common. But the FDA has largely ignored his appeals for transparency measures that would put more of this information in the hands of doctors and patients.

Under current rules, medications can be considered interchangeable (bioequivalent) by FDA if they range from 80 percent to 125 percent of the active ingredient availability of the innovator product. But for many medications, this range is simply too wide, especially if one is switched from one generic at the low end of the range to another at the high end. Narrowing the allowable range probably makes sense for the most sensitive drugs, and this is what Graedon wants. But as a start, the FDA could simply publish the bioequivalence data that all companies have to file with the agency. These data are not proprietary in any business sense, but publication would allow physicians to advise at-risk patients to not take certain products. To be fair, these data are not always easy to interpret, but surely physicians have the right to know them and to advise patients accordingly.

Right now most patients, and probably most physicians, don't even think about which generic medicine to choose. The substitution is typically automatic or at the discretion of a pharmacist. My team's ongoing research of the cholesterol-lowering medication atorvastatin (the generic of brand Lipitor) has found that in many pharmacies, patients are routinely bounced from one product to another, with the patient none the wiser.

For cardiologist Harry Lever, of the Cleveland Clinic, this is a problem. Dr. Lever routinely argues with insurers and pharmacists to ensure his patients get better medication, usually asking them to allow his patients to choose generic medications that are not manufactured in India. Most patients are not lucky enough to have Dr. Lever as their physician.

If we make quality data publicly available, physicians and patients could make better-informed decisions about their health. But, alas, that would undermine the FDA's facade, which is that all of the generic products it approves are identical. On numerous occasions Dr. Janet Woodcock, the key FDA official overseeing the new office, has said that she believes the public would not benefit from having access to drug-quality information.

Nonsense. When it comes to quality data on the medicines that we all consume, transparency should be a right. If FDA could ensure no defective products were on sale in US then its paternalism might be justified, but that is simply not the case.

Roger Bate is an adjunct fellow at the American Enterprise Institute and the author of Phake: The Deadly World of Falsified and Substandard Medicine.

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