Medical policy and regulation
Medical policy and regulation in healthcare ensure the safety, efficacy and quality of medical treatments and services by setting standards and guidelines for medical practices, drug development and healthcare delivery. Continuous updates and oversight in medical policy and regulation help guide clinical innovation and refine current approaches to healthcare.
Top Stories
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News
25 Oct 2024
TreeHouse Foods expands recall of waffles, pancakes
TreeHouse Foods expands its recall of waffles and pancakes from major retailers, like Walmart, Target, Aldi, Dollar General, Kroger, Publix, Whole Foods, Trader Joe's and more. Continue Reading
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17 Oct 2024
Medicare drug price negotiations impact non-chain pharmacies
Although Medicare drug price negotiations intend to expand medication access, independent pharmacies are facing challenges associated with reimbursement and PBM strategies. Continue Reading
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12 Jul 2023
White House National Response Plan Addresses Xylazine, Fentanyl Risk
In light of recent overdose trends, the White House has issued a national response plan that addresses the risks of fentanyl and xylazine. Continue Reading
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11 Jul 2023
Cipla Albuterol Sulfate Inhalation Aerosol Voluntarily Recalled
Cipla voluntarily recalled six batches of its albuterol sulfate inhalation aerosol due to a container defect. Continue Reading
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07 Jul 2023
Biogen and Eisai Secure Traditional FDA Approval for Lequembi
After reviewing the supplemental Biologics License Application, the FDA granted Biogen and Eisai’s Lequembi traditional approval. Continue Reading
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05 Jul 2023
Older and Immunocompromised Adults Advised to Get RSV Vaccine
Updated CDC recommendations advise older and immunocompromised adults to get the newly available RSV vaccines. Continue Reading
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30 Jun 2023
FDA Adds Another Frozen Fruit to Recall List: Listeria Contamination
Adding to a series of frozen fruit recalls linked to hepatitis A, the FDA has added some frozen pineapples to the recall list due to listeria contamination. Continue Reading
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Feature
29 Jun 2023
WMIF: FDA Commissioner Discusses Revamping Accelerated Approval
At the 2023 World Medical Innovation Forum (WMIF), the FDA Commissioner discussed revamping accelerated approval. Continue Reading
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Feature
28 Jun 2023
Biopharmaceutical Leaders Challenge the IRA’s Innovation Implications
As part of a panel at the WMIF, biopharmaceutical leaders challenged the IRA for its implications on and perceived challenges in innovation. Continue Reading
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27 Jun 2023
FDA Issues Guidance on Psychedelic Drug Use in Clinical Trials
The FDA has issued draft guidance on psychedelic drug use in clinical trials for the first time. Continue Reading
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22 Jun 2023
FDA Grants Bluebird Bio Priority Review of BLA for SCD Treatment
Bluebird Bio gets FDA priority review for SCD treatment in patients 12+ with vaso-occlusive history. Continue Reading
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21 Jun 2023
FDA Approves New Pediatric Medication for Type 2 Diabetes
FDA approves empagliflozin, a new class of pediatric drugs for type 2 diabetes, providing an alternative to metformin. Continue Reading
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20 Jun 2023
FDA Announce Additional Frozen Fruit Recall: Hepatitis A Contamination
FDA announces new recalls on frozen fruit due to potential hepatitis A contamination, following recent recalls. Continue Reading
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16 Jun 2023
FDA Provides Guidance for Preventing Contamination in Tattoo Ink
Following a previous safety alert, the FDA provided draft guidance for preventing and reducing microbial contamination in the tattoo ink in a recent press release. Continue Reading
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12 Jun 2023
Research Explores the Harmful Health Effects of Recycled Plastics
A research report published by Greenpeace advocating for the Global Plastics Treaty explores and highlights the harmful health effects of recycled plastics. Continue Reading
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09 Jun 2023
Sackler Family Granted Legal Immunity Despite Opioid Epidemic
The Sackler Family, owners of Purdue Pharma, were granted legal immunity from civil claims in exchange for a $6 billion payout to plaintiffs despite the continuing opioid epidemic. Continue Reading
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02 Jun 2023
FDA Proposes Amendment to Human Prescriptions Drug Labeling Guidelines
The FDA has proposed an amendment to the drug labeling guidelines for human prescription drugs, adding a Patient Medication Information section. Continue Reading
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31 May 2023
How Medical Affairs Impact the Pharmaceutical Industry
Despite being crucial for scientific communication between companies and industry leaders, the growing responsibility of medical affairs has contributed to various challenges. Continue Reading
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17 May 2023
FDA Advisory Committee Favors Approval of Intranasal Epinephrine
In a recent vote, an FDA advisory committee favored the approval of the first intranasal epinephrine spray, with a final decision anticipated in the coming months. Continue Reading
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16 May 2023
FDA Finalizes Blood Donation Guidelines, Expands Eligibility
A recent announcement by the FDA finalizing its blood donation guidelines expands donor eligibility by recommending individual risk assessments. Continue Reading
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12 May 2023
FDA Advisory Panel Favors Over-the-Counter Birth Control Pill: Opill
A Joint FDA advisory committee vote favored the over-the-counter sale of Opill, a female birth control pill. If enforced, this vote would widen access to contraceptive care. Continue Reading
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03 May 2023
FDA Publishes Draft Guidance for Decentralized Clinical Trials
On May 2, 2023, the FDA published a new draft guidance for decentralized clinical trials, building on 2020 guidance issued at the height of the COVID-19 pandemic. Continue Reading
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24 Apr 2023
FDA-Approved Cell Therapy Protects Patients After Stem Cell Transplant
Newly FDA-approved, Omisirge, a cell therapy, may protect patients with blood cancer from infection after a stem cell transplant. Continue Reading
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20 Apr 2023
FDA Updates EUA for Bivalent mRNA COVID-19 Vaccines to Simplify Use
This week, the FDA updated the bivalent mRNA COVID-19 vaccines EUA to simplify their use, allowing patients over 65 to receive a second bivalent booster. Continue Reading
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19 Apr 2023
FDA Guidance Won’t Recommend Another Booster for Most Individuals
The future of COVID-19 vaccinations will look similar to influenza shots, according to new FDA guidance. Continue Reading
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14 Apr 2023
DEA Issues Public Safety Alert for Fentanyl Mixed with Xylazine
As local health departments identified increased rates of laced fentanyl, the DEA issued a public safety alert for fentanyl mixed with xylazine. Continue Reading
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13 Apr 2023
Project NextGen Leverages $5 Billion for COVID Vaccine Development
The next phase of COVID-19 funding will seek new vaccines and better treatments for the vulnerable. Continue Reading
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12 Apr 2023
FDA Domestic and Foreign Oversight Protocols and Violation Responses
In light of recent findings from manufacturing inspections, it is critical to understand FDA oversight protocols, violation responses, and potential shortcomings domestically and internationally. Continue Reading
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11 Apr 2023
FDA Withdraws Approval of a Premature Birth Drug After 12 Years
After 12 years on the market, the FDA has withdrawn approval of Makena, a premature birth drug, and its generics due to inefficacy. Continue Reading
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10 Apr 2023
Federal Judge Rules to Reverse FDA Approval of Abortion Pill
A federal judge from Texas ruled to reverse the FDA approval of mifepristone, the abortion pill that has been approved since 2000. Continue Reading
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07 Apr 2023
FDA Requires Mail-Back Envelops with Opioid Analgesics Dispensation
A recent FDA press announcement revealed that the FDA would require mail-back envelopes to be distributed with opioid analgesic dispensation in outpatient settings. Continue Reading
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06 Apr 2023
HHS Releases National Cancer Plan to Further Cancer Moonshot
After the Biden administration relaunched the Cancer Moonshot in 2022, the HHS released a National Cancer Plan to further the initiative. Continue Reading
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05 Apr 2023
FDA Details Manufacturing Conditions That Led to Eye Drop Recall
In an inspection lasting from February 20 to March 2, the FDA discovered sanitary issues and dangerous pharmaceutical manufacturing processes at the Global Pharma eye drop plant. Continue Reading
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31 Mar 2023
WHO Updates COVID-19 Vaccination Guidance After March SAGE Meeting
After the March SAGE meeting on March 28, 2023, the WHO updated its COVID-19 vaccination guidance, providing vaccine and booster recommendations based on risk. Continue Reading
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30 Mar 2023
FDA Grants Approval to Emergent BioSolutions for Over-the-Counter Narcan
Naloxone 4 mg spray will be available in retail locations across the United States starting this summer. Continue Reading
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29 Mar 2023
FDA Issues Draft Guidance on Accelerated Approval for Oncology Drugs
A draft guidance issued by the FDA has recommended randomized controlled trials for the accelerated approval of oncology drugs and therapeutics. Continue Reading
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28 Mar 2023
Ohio Attorney General Sues Pharmacy Benefit Managers Due to Collusion
The Ohio Attorney General, Dave Yost, sued pharmacy benefit managers from multiple organizations because they colluded during drug price negotiations. Continue Reading
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27 Mar 2023
HRSA Announces Plans to Overhaul Organ Procurement Transplant Network
In light of failures in the organ transplant system, the HRSA announced plans to overhaul the organ procurement and transplant network. Continue Reading
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22 Mar 2023
California Partners with Civica to Make Affordable Insulin Available
Governor Gavin Newson announced that CalRx, a program through the California Department of Healthcare Services, is partnering with Civica to make affordable insulin available state-wide. Continue Reading
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21 Mar 2023
FDA Announces Recall of Frozen Fruit from Costco, Aldi, Trader Joe’s
The FDA recently announced a voluntary recall of frozen fruit sold at Costco, Aldi, and Trader Joe’s due to hepatitis A contamination. Continue Reading
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20 Mar 2023
Pfizer Recalls Migraine Medication Under Advisement From CPSC
The Consumer Product Safety Commission recently advised Pfizer to recall Nurtec ODT due to flaws in child-resistant packaging. Continue Reading
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14 Mar 2023
FDA Requires Anaphylaxis Warning for All Allergenic Extracts
In a recent safety communication, the FDA announced that it would require an anaphylaxis warning for all allergenic extracts used to diagnose food allergies. Continue Reading
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13 Mar 2023
Regulating and Authorizing Medicines: A Comparison of the FDA and EMA
Comparing the EMA and FDA pathways for regulating and authorizing medications may explain approval patterns and protocols for new drugs. Continue Reading
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10 Mar 2023
Behind Walgreens’ Decision to Forgo Abortion Pill Distribution in Some States
Walgreens’ recent decision to limit its abortion pill distribution to some areas of the United States was met with pushback by California Governor Gavin Newsom and others. Continue Reading
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09 Mar 2023
FDA Adds Two Eye Drops to Its Recall List Due to Supply Chain Issues
After recalling batches of artificial tears in early February, the FDA has added two eye drops to its recall list due to supply chain issues. Continue Reading
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01 Mar 2023
DEA Proposes Updated Rules to COVID-19 Telemedicine Flexibilities
The DEA recently proposed an update to telemedicine prescribing rules, amending COVID-19 telemedicine flexibilities by extending some allowances and restricting others. Continue Reading
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24 Feb 2023
Reckitt Recalls Plant-Based Infant Formula Due to Health Risk
On February 20, 2023, Reckitt recalled two select batches of Enfamil 12.9 oz ProSobee Simply Plant-Based Infant Formula due to potential health risks caused by bacterial contamination. Continue Reading
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22 Feb 2023
Other Countries Refused 47 FDA-Approved Drugs in the United States
A recent assessment of FDA-approved drugs between 2017 and 2022 determined that other countries refused to approve or discouraged reimbursement for 47 drugs approved in the United States. Continue Reading
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14 Feb 2023
Legalizing Recreational Cannabis May Reduce Some Opioid Distribution
An article published in Health Economics found that legalizing recreational cannabis may reduce the demand for opioids, thus reducing distribution and its potential risks. Continue Reading
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13 Feb 2023
CDC Updates Pediatric Immunization Schedule, Including COVID Vaccine
The CDC updated its 2023 pediatric immunization schedule to include recommendations for the COVID-19 vaccine starting at six months old. Continue Reading
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10 Feb 2023
Washington State Takes Regulatory Steps Toward Non-Toxic Cosmetics
With supporting data from the Washington State Department of Ecology, Washington state has taken regulatory steps toward non-toxic cosmetics. Continue Reading
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08 Feb 2023
Global Pharma Healthcare Recalls Artificial Tears Due to Contamination
After the CDC identified bacterial infections, the FDA announced that Global Pharma Healthcare had voluntarily recalled its artificial tears due to contamination by Pseudomonas aeruginosa. Continue Reading
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03 Feb 2023
FDA Commissioner Announces New Vision for Human Foods Program
In response to a report from the Reagan-Udall Foundation and an internal FDA review, the FDA commissioner, Robert M. Califf, announces a new vision for the Human Foods Program. Continue Reading
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31 Jan 2023
How Naloxone Co-Prescribing Laws Can Facilitate Opioid Education
Legislation regarding naloxone and opioid co-prescribing laws may facilitate opioid education by allowing healthcare professionals to discuss the risk of opioid use and emergency overdose care. Continue Reading
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31 Jan 2023
FDA Issues Draft Guidance Regarding Lead Levels in Processed Baby Food
In an announcement released on January 24, 2023, the FDA issued a draft guidance regarding lead levels in processed baby food, specifically those marketed for children under two. Continue Reading
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30 Jan 2023
FDA Issues Draft Recommendation for Updated Blood Donation Guidelines
Current blood donation restrictions in the US discriminate against donations from gay and transgender individuals; however, the FDA recently issued a draft recommendation for updating the blood donation guidelines, encouraging individual assessments. Continue Reading
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30 Jan 2023
NIH Published Draft Recommendation for Pandemic Pathogen Research
Echoing concerns from the GAO, the NIH recently published a draft recommendation for potential pandemic pathogen research, analyzing and amending current guidelines. Continue Reading
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20 Jan 2023
The FDA Modernization Act 2.0 Allows Animal Trials Alternatives
The FDA Modernization Act 2.0, signed by President Biden, allows clinical trial leaders to use animal trial alternatives instead of traditional animal modeling for drug and biological development. Continue Reading
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17 Jan 2023
Policy in Practice: How the Influenza Act Would Influence Healthcare
If approved, the Influenza Act, introduced in December 2022, could influence healthcare practices surrounding seasonal and pandemic influenza. Continue Reading
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13 Jan 2023
Clinical Guidelines for Pediatric Obesity Encourage Early Intervention
For the first time in 15 years, the clinical guidelines for pediatric obesity have been updated to encourage early interventions such as medication and surgery. Continue Reading
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10 Jan 2023
FDA Accelerates Approval of a New Alzheimer’s Disease Drug, Leqembi
On Friday, January 6, 2023, the FDA accelerated the approval of Leqembi, a new medication targeting the pathophysiology of Alzheimer’s disease. Continue Reading
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09 Jan 2023
EPA to Propose National Drinking Water Regulations
In 2023, the EPA plans to propose and enforce national drinking water regulations to minimize the presence of PFOA and PFOS, chemical compounds with many healthcare implications. Continue Reading
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04 Jan 2023
FDA Expands Access to Abortion Pills in Retail Pharmacies
After long deliberation, the FDA has expanded access to abortion pills, allowing retail pharmacies to distribute the medication. Continue Reading
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03 Jan 2023
Understanding Pharmaceutical Recalls, Key Players, and Their Roles
For key players such as the FDA, manufacturers, and other healthcare professionals, understanding pharmaceutical recalls, procedures, and obligations are necessary for ensuring patient safety. Continue Reading
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29 Dec 2022
FDA Grants Approval for HIV Treatment to Fight Drug Resistance
Gilead received approval for a novel twice-yearly treatment offering another option for fighting drug-resistant HIV. Continue Reading
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21 Dec 2022
FDA Approves New Adjunctive Treatment for Depression
On December 16, 2022, the FDA approved VRAYLAR, known generically as cariprazine, as an adjunctive treatment for depression. Continue Reading
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19 Dec 2022
How to Improve Regulatory Measures for Dietary Supplements
Considering that 80% of adults in the United States use or have used dietary supplements, improvements to the current regulatory measures for dietary supplements are vital. Continue Reading
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16 Dec 2022
Janssen Submits Biologics License Application for Talquetamab
On December 9, 2022, Janssen announced its submission of a Biologics License Application for talquetamab to treat relapsed or refractory multiple myeloma. Continue Reading
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12 Dec 2022
Understanding FDA Advisory Committees, Aims, and Members
The FDA advisory committees, composed of multiple members of different disciplines, aim to provide evidence-based recommendations for the FDA’s regulatory decisions. Continue Reading
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09 Dec 2022
ACMA Announces Board Certification Program for Biologics, Biosimilars
The ACMA announced a self-paced, online board certification program for biologics and biosimilars. Continue Reading
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30 Nov 2022
FDA Investigates Prolia’s Association with Severe Hypocalcemia
In a recent drug safety communication, the FDA announced that it is investigating Prolia, an osteoporosis medication, and its association with severe hypocalcemia in patients on dialysis. Continue Reading
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29 Nov 2022
FDA Grants IND Approval for Prostate Cancer Clinical Trial
On November 21, 2022, the FDA granted IND approval to begin studying theranostic SAR-Bombesin for the treatment of prostate cancer in a clinical trial. Continue Reading
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22 Nov 2022
FDA Approves ELAHERE for Ovarian Cancer
In a recent press release, ImmunoGen announced that the FDA has granted the organization accelerated approval for ELAHERE to treat platinum-resistant ovarian cancer. Continue Reading
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21 Nov 2022
FDA Approves TZIELD to Delay Stage 3 Type 1 Diabetes
On November 17, 2022, the FDA approved TZIELD, the only treatment to delay Stage 3 type 1 diabetes in patients eight years old and older with Stage 2 type 1 diabetes. Continue Reading
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18 Nov 2022
FDA Recommends New Asthma Rescue Treatment
In a nearly unanimous vote on November 9, 2022, an FDA advisory committee recommended PT027, a new rescue treatment for asthma. Continue Reading
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09 Nov 2022
Unpacking the 340B Drug Pricing Program, Its Impact on the Pharmaceutical Industry
The 340B Drug Pricing Program is a key resource for outpatient prescription drug access, but recent conflicts have altered the pharmaceutical industry’s role in the federal program. Continue Reading
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02 Nov 2022
Understanding the FDA’s Expedited Approval Pathways
Understanding the FDA’s expedited approval pathways, Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval, is essential for patients, payers, and providers, as a majority of approved drugs in 2021 underwent one of these procedures. Continue Reading
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20 Oct 2022
Novartis Is Losing Its Battle Against a Generic Drug for MS
The United States Supreme Court lifted a previous ban and will allow generic versions of Novartis’s multiple sclerosis drug, Gilenya, to be sold in the US. Continue Reading
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07 Oct 2022
President Biden Calls for Reform on Marijuana Regulation
In a brief released yesterday by the White House, the Biden administration called for a reform of marijuana regulation. Continue Reading
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30 Sep 2022
FDA Approves Relyvrio for ALS Treatment
After a long-winded path to development and approval, the FDA approved Relyvrio, previously called AMX0035, developed by Amylyx pharmaceuticals for ALS treatment. Continue Reading
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28 Sep 2022
How Federal and State Laws Have Hindered Access to OUD Treatment
A recent review published by Pew Charitable Trusts found that federal and state laws, predominantly not evidence-based, have hindered access to opioid use disorder (OUD) treatment. Continue Reading
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27 Sep 2022
FDA Approved Psilocybin Investigational New Drug Application
The FDA recently approved an investigational new drug application for psilocybin to be used in eating disorder treatment. Continue Reading
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27 Sep 2022
How A Prescription Drug Becomes Available Over the Counter
Considering the recent efforts to make oral contraceptives available over the counter, understanding the FDA guidelines on how a drug becomes available over the counter is essential for the industry. Continue Reading
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23 Sep 2022
US FDA Accelerated Approval for 48 Non-oncology Drugs
A recent study published in JAMA Network Open found that between 1992 and 2018, the FDA accelerated the approval for 48 non-oncology drugs. Continue Reading
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20 Sep 2022
Understanding Antimicrobial Stewardship and Applications in Healthcare
In a recent interview with PharmaNewsIntelligence, Michael Bozzella, DO, explained antimicrobial stewardship practices and their applications across different healthcare landscapes. Continue Reading
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19 Sep 2022
How Biden’s Equitable Access to Research Will Impact Healthcare
In an interview with PharmaNewsIntelligence, Ariel Katz, CEO of H1, a global healthcare data provider, discussed how the Biden administration’s order for equitable access to research will impact healthcare. Continue Reading
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14 Sep 2022
Medications in the US Are More Widely Available than in Germany
A recent JAMA Network Open study determined that medications are more widely available and are available sooner in the United States than in Germany. Continue Reading
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09 Sep 2022
Federal Judge Rules against Mandated HIV PrEP Coverage
A federal judge in Texas ruled against mandated HIV PrEP coverage, citing religious freedom as the cause. Continue Reading
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02 Sep 2022
FDA Approves Bivalent COVID Boosters
On August 31, 2022, the FDA approved the bivalent Moderna COVID-19 vaccine and the Pfizer–BioNTech COVID-19 vaccine for use as a booster. Continue Reading
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01 Sep 2022
FDA Approved the Use of Omnipod 5 for Children Over 2
Recently, the FDA approved the use of Omnipod 5 for children over 2 with type 1 diabetes, expanding on its previous approval, which only allowed for use in people over 6 years old. Continue Reading
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31 Aug 2022
WHO Recommends Use of Monoclonal Antibodies in Ebola Treatment
On August 19, 2022, the WHO released its first recommendations for using monoclonal antibodies to treat Ebola. Continue Reading
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30 Aug 2022
FDA Approved AUVELITY for Major Depressive Disorder in Adults
The FDA recently approved AUVELITY, an oral medication, for the treatment of major depressive disorder in adults. Continue Reading
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29 Aug 2022
FDA Approves Mirena for 8 Years
The FDA recently approved a supplemental new drug application for Mirena, which extended the use duration by one year for a total of eight years. Continue Reading
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26 Aug 2022
FDA Expands Emergency Use Authorization for Novavax COVID Vaccine in Kids
On Friday, August 19, 2022, the FDA expanded the emergency use authorization (EUA) for the Novavax COVID vaccine allowing it to be used in children between the ages of 12 and 17. Continue Reading
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23 Aug 2022
FDA Approves Cell-Based Gene Therapy for Patients with Beta Thalassemia
The FDA recently approved the first cell-based gene therapy for patients with beta thalassemia in pediatric and adult patients. Continue Reading
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22 Aug 2022
FDA Approves the Sale of Hearing Aids over the Counter
On Tuesday, August 16, the FDA issued a final ruling that approved the over-the-counter sale of hearing aids. Continue Reading
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17 Aug 2022
FDA Considers Dividing Monkeypox Vaccine Doses
Under the Biden administration, the FDA considers dose sparing by dividing the monkeypox vaccine doses into fifths. Continue Reading
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15 Aug 2022
Update on FDA Review and Enforcement of Non-Tobacco Nicotine Products
On August 3, 2022, Brian King, Director of the FDA’s Center for Tobacco Products, made a statement regarding the FDA Review and Enforcement of Non-Tobacco Nicotine Products update. Continue Reading
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09 Aug 2022
Lyons Magnus Recalls Products due to Microbial Contamination
Recently, Lyons Magnus LLC voluntarily recalled several of its beverages for concerns of microbial contamination. Continue Reading
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20 Jul 2022
CDC Recommends Novavax COVID Vaccine
Yesterday, an announcement by the CDC recommended the Novavax COVID vaccine as an additional primary vaccine for adults. Continue Reading
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15 Jul 2022
HHS Issues Pharmacies’ Obligation to Ensure Access to Reproductive Care
On July 13, 2022, the United States HHS outlined guidance on pharmacies’ obligation to ensure access to reproductive healthcare. Continue Reading
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12 Jul 2022
HRA Pharma Submits FDA Application for First OTC Birth Control Pill
HRA Pharma recently submitted its FDA application to allow the company’s birth control pill to be sold over the counter (OTC), which would make it the first OTC birth control pill. Continue Reading