Timeline for the drug development and approval dates for FDA submission.
The isotretinoin drug compound was first researched by Werner Bollag as a treatment for skin cancer in the 1960s at Roche labs in Switzerland. The research was completed in 1971 and surprisingly found that the compounds were more effective for managing acne than skin cancer. Roche stopped working on the product in 1975 but later resumed working on the drug. In 1982, the FDA allowed the use of the drug. In 1983 FDA warned against the drug as there were many congenital disabilities seen in patients who were using the drug (Danby, 2015). In 2000 discussed how that could be implemented to prevent expectant women from getting exposure to the drug. In 2002 FDA allowed other companies to manufacture generic versions of the drug at cheaper rates. In 2009 Roche discounted manufacturing the drug.
An overview of the sponsoring company and the drug treatment area.
Roche was given the legal right to manufacture the drug Isotretinoin back in 1962, and it was licensed in 1982 for medical use. Owing to the availability of the various generic variants and the settlement of several actions over the drug’s side effects, Roche agreed to discontinue production due to the declining market share (Danby, 2015).
Isotretinoin is used to manage severe acne that has not been cured by other drugs like antibiotics. Isotretinoin belongs to a family of drugs called retinoids. It works by slowing down the formation of some natural compounds that causes acne. Depending on the dosage been administered, many individuals who receive isotretinoin will be acne free by the end of 4 to 6 months of the drug treatment. Isotretinoin is currently approved as the second-line treatment to treat extreme acne in cases that do not respond to other treatment combinations. Physicians have recommended isotretinoin as the first-line treatment in managing extreme acne over the past years. Also, to those with weak prognostic characteristics as well as conditions associated with severe acne. The drug is not recommended for children under 12 years of age (Danby, 2015).
Isotretinoin is also effective in hidradenitis suppurativa and certain extreme rosacea cases (Plewig et al., 2019). It can also help manage lamellar ichthyosis, ichthyosis of harlequin, and in xeroderma pigmentosum to alleviate keratosis. The drug was also used to manage progressive fibrodysplasia ossificans, a very rare disease. It can also be used in the management of neuroblastoma, a type of nerve cancer. Besides, Isotretinoin has proven to be effective in managing genital warts though it is hardly used for this indication because there are other more effective therapies.
The profitability of the drug, including the length of time it has been on the market.
Isotretinoin has been in the market since 1982. Company manufacturing had gained lots of profit since the drug was accepted in the market, and many individuals used it to treat severe acne. Doctors and hospitals also benefited from the drug and gained huge profits as the drug was previously used as the first-line treatment in severe acne cases. Roche had gained lots of profits since it was the only company manufacturing the drug from 1982 until 2002 when other companies were allowed to manufacture a generic drug. Roche has sold the drug to around 13 million people; therefore, they gained high profits by selling drugs (Plewig et al., 2019).
Did the recall violate specific parts of any applicable law?
The recall did not violate specific parts of any applicable law since the drug had some teratogenic effects on patients after they consumed it (Bahri, 2020).
Overview of the recall issue, including the number of patients that were affected.
Isotretinoin has been in use for many years since it was first manufactured. Isotretinoin was recalled in 2009 after increased concerns about its effects. The drug has some teratogenic effects, though it has been effective in the management of severe acne. Roche has sold the drug to around 13 million people. Cases of congenital disabilities were established during the first year of the drug use, and an estimated number of 1000 babies were born with congenital disabilities. Around 1000, women had miscarriages after being exposed to isotretinoin treatment. An estimated number of 5000 to 7000 women had abortions after using isotretinoin. If taken during pregnancy or even a short time before conception, isotretinoin is extremely teratogenic and can result in congenital disabilities (Plewig et al., 2019). Some congenital disabilities include; inability to hear, blindness, missing earlobes, abnormalities of the brain, and facial malformation.
The number of individuals affected by isotretinoin it was established cannot be calculated. There was also some increased risk of inflammatory bowel disease after using isotretinoin treatment (Plewig et al., 2019). Roche cited the increasing cost of isotretinoin lawsuits involving allegations brought by former patients who have suffered serious bowel issues after using the drug as a justification for withdrawing the product from the market. While many individuals point to the withdrawal of isotretinoin from the market as a recall, the FDA in 2009 established that Roche did not recall the drug for safety.
Most lawsuits filed against Roche state that isotretinoin recall could have been released by the drug manufacturer years earlier. This is because the drug’s benefits tend to be outweighed in many instances by the possibility of serious adverse effects of the drug. Thousands of cases involving users who have acquired isotretinoin inflammatory bowel disease may involve isotretinoin ulcerative colitis, and isotretinoin Crohn’s disease is still pending (Danby, 2015).
The response of the FDA, drug sponsor, and the general public to the recall.
The FDA warned the public that they should not buy the drug without the doctor’s review and prescription due to its teratogenic nature. The Drug sponsors stated that the increasing cost of isotretinoin lawsuits involving allegations brought by patients who have suffered serious bowel issues after using the drug was the reason for withdrawing the product from the market. The general public stated that the drug could have been recalled years before when patients experienced adverse drug reactions. This is because the drug caused more harm than benefits when consumed by patients (Bahri, 2020).
Actions taken by the FDA and the Drug sponsor in response to the recall.
There were actions taken by the FDA and drug sponsor in response to the recall. FDA investigated the claims issued by the patients on the adverse effects caused by the drug. The FDA also issued a report that all patients under the drug to be monitored closely, especially pregnant women who were at more risk of miscarriages, abortions, and defects. The FDA also came up with programs to ensure that pregnant women or planning to get pregnant must not be prescribed isotretinoin. Under those programs,’ patients would be given the drug prescription if they met the iPLEDGE requirements. Drug sponsors like Rocha stopped manufacturing the drug after the recall. Other companies started to manufacture the generic form of isotretinoin after Rocha stopped selling the drug (Bahri, 2020).
What are the changes to make this drug back into the market?
Generic versions of the drug are still available in the market. When Roche stopped manufacturing the drug in 2009, other companies came up and produced the drug-using other trade names. Probable changes made to make the drug available in the market may include; putting strict measures on the drug purchase like people should not be sold for the frug without a doctor’s prescription. Doctors should conduct pregnancy check-ups on women to a certain that they are not pregnant before prescribing the drug. This is due to the drug’s teratogenic nature and the adverse effects it has caused by pregnant women. Patient monitoring should be emphasized to look out for the effects of drug-like mental health issues, bowel diseases, and other adverse effects of the drug. Other changes include; making the drug the last option in the treatment of acne (Danby, 2015). Since acne is not a life-threatening condition, other treatment options should be considered before prescribing isotretinoin as the first line treatment. Strict measures were put in place, whereby doctors are not allowed to use isotretinoin as the first option to treat acne.