FDA Faulted For Inability To Properly Manage Drug Risks

The Office of the Inspector General (OIG) at the Department of Health and Human Services has recently released a report calling into question the effectiveness of the Food and Drug Administration’s (FDA) strategy for managing drug risks.

The OIG said they did the study because The Food and Drug Administration (FDA) requires manufacturers to submit structured plans, known as Risk Evaluation and Mitigation Strategies (REMS), for drugs associated with known or potential risks that may outweigh the drugs’ benefits. If the FDA does not properly monitor REMS’ performance, it cannot ensure that the public is provided maximum protection from a drug’s known or potential risks. However, the FDA does not have the authority to require, but may request, drug manufacturers (i.e., sponsors) to submit specific information regarding REMS’ effectiveness.

The FDA uses REMS in situations where regulators have significant concerns that a drug has an unpredictable, severe, and potentially avoidable risk. REMS are a strategy the FDA first adopted in the late 1990s as “voluntary” agreements that drug makers make with the agency. Sponsors would enter in to these arrangements with the FDA as a condition of approval. In most cases, the companies promised to put in place restrictions on how drugs would be used by doctors. These limitations were meant to help mitigate the agency’s safety concerns, and make it easier to get a new product to the market.

These plans might, for example, involve pregnancy testing before woman can use a drug that is known to cause birth defects; or for drugs that could cause an immediate and severe allergic reaction (anaphylaxis), special monitoring of patients when they first received the medicine. Another situation where these risk mitigation plans were used involved scheduled narcotics that could be accidentally ingested by children. The FDA often required risk management plans that would help keep the narcotic drugs secure in the home and out of the hands of small kids.

Over the years, these arrangements evolved. They became dubbed REMS in 2007 when the FDA received explicit authority from Congress to demand these arrangements are part of drug approvals. Gone was the “voluntary” nature of the scheme, where the FDA would effectively pressure companies into agreeing to the restrictions in order to get their products approved. After 2007, the FDA had the explicit legal authority to demand the restrictions. But Congress also tasked the FDA with oversight to make sure that the programs were having their intended public health benefits.

The OIG report reviewed approved REMS implemented since the program’s “legal” inception in 2008, all the way through 2011. The FDA approved 199 REMS over that time; 99 of which were still required in 2012. Nearly half of the assessments for the 49 REMS that the OIG reviewed did not include all information requested in the FDA “assessment plans,” and 10 were not submitted to the FDA within required timeframes. The FDA determined that only 7 of the 49 REMS reviewed met all of their goals.

The OIG stated in their report that their “findings raise concerns about the overall effectiveness of the REMS program.”  To address these concerns, they made seven recommendations regarding the FDA’s evaluation and assessment of REMS and its review of sponsors’ REMS assessments. The FDA concurred with six of our recommendations. For the remaining recommendation, to seek legislative authority to make the FDA assessment plans enforceable, the FDA did not state whether it concurred or did not concur. However, the FDA agreed that this recommendation should be considered if another opportunity arises to pursue legislative changes to the statutory provisions that describe the requirements for REMS assessments.

Although, according to the recent report, OIG says that the FDA fell short in how it implemented the provisions, is it really their fault?  Or is the system set up to fail?

According to an article in Forbes, “It was inevitable that these strategies would be hard to execute, and even more difficult to impose and monitor. The risk mitigation plans presupposed that the FDA and the drug makers had legal, if actual control over what doctors did and how they prescribed medicines. The FDA doesn’t have this authority and drug makers can’t exercise that sort of control.”

, , , , , ,

No comments yet.

Leave a Reply

  • This field is for validation purposes and should be left unchanged.
Latest Drug Injury News

Merck’s Falsification of Vaccine Data Exposed

Merk’s dirty little secret has been exposed. A pair of lawsuits, one filed by former employees of Merck and the other by doctors, alleged the company knew its mumps vaccine was less effective than the supposed 95 percent efficiency level. According to court documents the former virologists employed by Merck filed a whistleblower lawsuit four […]

Testosterone Therapy Linked To Heart-Attack, Stroke and Death

Millions of men have turned to testosterone therapy to treat symptoms of aging. However, they may not be aware that they are putting themselves at risk for heart attack or stroke. According to the latest study published in the journal PLOS ONE, researchers report that within 90 days of taking the hormone the risk of […]

What Is Doribax?

According to the FDA the antibacterial drug Doribax, that has been used to treat patients who develop pneumonia on ventilators, carries an increased risk of death and has a lower clinical cure rate by injection compared a similar drug known as Primaxin. What is Doribax? Doribax is an antibiotic that fights serious infections caused by […]

Is Using Tylenol or Ibuprofen During Pregnancy linked to ADHD?

What is a mother to do if she becomes ill during pregnancy?  The risks of consuming common drugs when pregnant are complex.  Although many doctors assure mothers that taking Tylenol is safe, a recent study by JAMA Pediatrics suggests otherwise.  The study found that mothers who used Tylenol for fever reduction while pregnant reported greater […]

Paxil Linked To Breast Cancer

City of Hope Cancer researchers indicate that a new test called the AroER Tri-Screen, desgined to look for drug side effects that could cause cancer, found a potential link between Paxil and breast cancer.  Paxil is a widely prescribed anti depressant. Research Researchers have found that Paxil has a weak estrogen effect that could increase […]

Latest Medical Device Injury News

Report Raises Concerns Over Heart Defibrillator Leads

The Food and Drug Administration (FDA) has just announced that they received a report that a St. Jude Durata cardiac defibrillator lead conductor became externalized; meaning the wire carrying electricity from the heart defibrillator to the heart was exposed through its insulation, a potentially dangerous and life-threatening defect.

HeartSine Class 1 Defibrillator Recall

HeartSine sent out a letter to customers in September, warning that the defibrillators may intermittently turn on and off, eventually depleting the battery.

FDA Medical Device Approval Based On Little Evidence

More than half of the high-risk cardiovascular devices approved in the past decade had no supporting active control data.

St. Jude Medical Gets FDA Warning

St. Jude Medical Inc. said it received a FDA warning about manufacturing and quality-control problems at its Sylmar, California, plant.

Hospira Still Facing Manufacturing And Regulatory Issues

Hospira has sent out 11 device notifications so far in 2013, including recall and device corrections. The company also said it sent notices to customers about some of its infusion pumps that had to either be recalled, fixed or adjusted.